Pap system

ABSTRACT

A PAP system includes a PAP device to generate a supply of pressurized air, a patient interface adapted to form a seal with the patient&#39;s face, air delivery tubing to interconnect the patient interface and the PAP device, and a cover that substantially encloses at least a portion of the PAP device and a portion of the air delivery tubing. The cover allows the PAP device to be carried by and/or supported on the patient&#39;s head.

CROSS-REFERENCE TO APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/457,858, filed Jun. 21, 2011, which is incorporated herein byreference in its entirety.

FIELD OF TECHNOLOGY

The present technology relates to Positive Airway Pressure (PAP) systemsand/or methods of use for treatment, e.g., of Sleep Disordered Breathing(SDB) with Continuous Positive Airway Pressure (CPAP) or Non-InvasivePositive Pressure Ventilation (NIPPV).

BACKGROUND OF TECHNOLOGY

Examples of head mounted blowers, wearable CPAP, or portable CPAP areknown in the art. For example, see U.S. Patent Application Publications2006/0237013 A1 and 2009/0320842 A1, each incorporated herein byreference, and the BreatheX™ system.

SUMMARY OF TECHNOLOGY

One aspect of the disclosed technology relates to PAP system including aPAP device for delivering pressurized air.

Another aspect of the disclosed technology relates to a PAP systemincluding a cover that substantially encloses one or more portions ofthe PAP device and air delivery tubing.

Another aspect of the disclosed technology relates to a PAP system thatis comfortable, less obtrusive, low impact, simplistic, easy todisassemble and clean, and/or low profile.

Another aspect of the disclosed technology relates to a PAP system thatis comfortable to sleep with regardless of sleeping position.

Another aspect of the disclosed technology relates to a wearable PAPsystem that is minimal and appears wearable, so overall perception isimproved (not like medical plumbing).

Another aspect of the disclosed technology is directed towards movingfrom a PAP system being used for “medical” reasons (e.g., CPAP fortreatment of OSA) to a PAP system being used for general health reasons(e.g., snoring, asthma, occupational, allergies, sports, self-analysisof sleep). In an example, the PAP system may be obtained without aprescription, i.e., shift away from a physician and towards theconsumer.

Another aspect of the disclosed technology relates to a PAP systemincluding one or more components (e.g., patient interface, air deliverytubing, headgear) constructed of materials including different colors,patterns, and/or surface texture so as to blend in with the patient'sskin and/or hair.

Another aspect of the disclosed technology relates to PAP systemsincluding headgear straps and/or covers that wrap around the patient'shead, a PAP device positioned on or adjacent the patient's head, bandanaor scarf-like covers that cover the patient's face, and/or air deliverytubing passing along the patient's head.

Another aspect of the disclosed technology relates to a PAP systemincluding a PAP device to generate a supply of pressurized air, apatient interface adapted to form a seal with the patient's face, airdelivery tubing to interconnect the patient interface and the PAPdevice, and a cover that substantially encloses at least a portion ofthe PAP device and a portion of the air delivery tubing. The cover mayallow the PAP device to be carried by and/or supported on the patient'sbody or head.

Another aspect of the disclosed technology relates to a system fordelivery of pressurized air to a patient including a base unit includinga blower to generate a supply of air at positive pressure, a patientinterface adapted to be provided to a patient's face, and a tube todeliver the supply of pressurized air to the patient interface. The tubeis structured to selectively modify its shape in order to move thepatient interface and/or modify the amount of force exerted between thepatient interface and the patient.

Another aspect of the disclosed technology relates to a mask systemincluding a patient interface to communicate with at least one of thepatient's airways, a sensor to generate a signal, e.g., related topatient breathing and/or movement, and a controller to receive thesignal and to initiate a response, e.g., to adjust force, seal, and/orposition of the patient interface relative to the patient. In anexample, the signal may include patient movement and/or sleepingpattern, leak, leak location, and/or torque. In an example, the responsemay include angle adjustment of the patient interface and/or forceprovided by the patient interface. In an example, the response may becustomized by the patient and/or physician.

Other aspects, features, and advantages of this technology will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thistechnology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousexamples of this technology. In such drawings:

FIG. 1 is a front view of a headworn PAP system according to an exampleof the present technology;

FIG. 2 is a side view of the PAP system of FIG. 1;

FIG. 3 is a side perspective view of the PAP system of FIG. 1 in use;

FIGS. 3A and 3B are exemplary cross-sections through the PAP system ofFIG. 3;

FIG. 4 is an exploded view of the PAP device of FIG. 1;

FIG. 5 is a side view of the PAP system of FIG. 1 in use;

FIG. 6 is a front perspective view of the PAP system of FIG. 1;

FIG. 7 is a front view of a PAP system according to another example ofthe present technology;

FIG. 8 is a side view of the PAP system of FIG. 7;

FIG. 9 is a top perspective view of the PAP system of FIG. 7 in use;

FIG. 9A is an exemplary cross-section through the PAP system of FIG. 9;

FIG. 10 is a side view of the PAP system of FIG. 7 in use;

FIG. 11 is an exploded view of the PAP device of FIG. 7;

FIG. 12 is another exploded view of the PAP device of FIG. 7;

FIG. 13 is a front view of a PAP system according to another example ofthe present technology;

FIG. 14 is a side view of the PAP system of FIG. 13;

FIG. 15 is a front perspective view of the PAP system of FIG. 13 in use;

FIG. 16 is a perspective view of a PAP device and cover of the PAPsystem of FIG. 13;

FIG. 17 is a rear perspective view of the PAP system of FIG. 13 in use;

FIG. 18 is an exploded view of the PAP device of FIG. 13;

FIGS. 19 to 42 show PAP systems according to alternative examples of thepresent technology;

FIG. 43 is a schematic view showing exemplary zones for positioning aPAP device relative to the patient's head according to an example of thepresent technology;

FIG. 44 is a schematic view of a PAP system according to another exampleof the present technology;

FIG. 45 is a schematic view of a PAP system according to another exampleof the present technology;

FIG. 46 is a perspective view of a PAP system in use according to anexample of the present technology;

FIG. 47 is another perspective view of the PAP system of FIG. 46 in use;

FIG. 48 is another perspective view of the PAP system of FIG. 46 in use;

FIGS. 49-1 to 49-6 show a retaining structure for a PAP device accordingto alternative examples of the present technology;

FIGS. 50, 51, 52, and 53 are various perspective views of a PAP systemin use according to an example of the present technology;

FIGS. 54, 55, and 56 are perspective views of a patient interface withan angled elbow joint according to an example of the present technology;

FIG. 57 is a perspective view of an angled elbow joint according to anexample of the present technology;

FIGS. 58 and 59 are perspective views of a patient interface accordingto an example of the present technology;

FIG. 60 is a perspective view of a base portion of a patient interfaceaccording to an example of the present technology;

FIG. 61 is a perspective view of a PAP system according to an example ofthe present technology;

FIGS. 62 and 63 show reversible positions of the PAP system of FIG. 61;

FIG. 64 is a perspective view of a PAP system according to an example ofthe present technology;

FIG. 65 is a perspective view of the PAP system of FIG. 64;

FIG. 66 is an exploded view of the PAP system of FIG. 64;

FIG. 67 is a perspective view of a PAP device of the PAP system of FIG.64;

FIG. 68 is a perspective view of the PAP system of FIG. 64 in use;

FIG. 69 is a perspective view of headgear of the PAP system of FIG. 64;

FIG. 70 is a perspective view of the PAP system of FIG. 64 in use;

FIG. 71 is a perspective view of the enclosed PAP device of the PAPsystem of FIG. 64;

FIG. 72 is a perspective view of a connection tab within headgear of aPAP system according to an example of the present technology;

FIG. 73 is a perspective view of connection tabs within headgear of aPAP system according to an example of the present technology;

FIG. 74 is a perspective view of a connection post within headgear of aPAP system according to an example of the present technology;

FIG. 75 is a cross-sectional view showing the connection post of FIG.74;

FIG. 76 is a perspective view of a PAP system including an alignment nubaccording to an example of the present technology;

FIG. 77 is a schematic view of a PAP system including alignment nubsaccording to an example of the present technology;

FIG. 78 is a schematic view of a PAP system including magnetic alignmentnubs according to an example of the present technology;

FIGS. 79, 80, and 81 show various views of a patient interface includingextended connectors tucked into headgear straps according to an exampleof the present technology;

FIGS. 82 and 83 are various views of a patient interface with a rotatingrigid elbow according to an example of the present technology;

FIG. 84 is a perspective view of the elbow of FIGS. 82 and 83;

FIG. 85 is a front view of a patient interface with a rotating rigidelbow according to an example of the present technology;

FIGS. 86 and 87 are various views of a one piece patient interface andair delivery tube according to an example of the present technology;

FIGS. 88 and 89 are various views of a patient interface with a directconnection to an air delivery tube according to an example of thepresent technology;

FIGS. 90, 91, and 92 are various views of a PAP system powered byinduction according to an example of the present technology;

FIGS. 93 and 94 show a PAP device according to an example of the presenttechnology;

FIG. 95 shows the PAP device of FIGS. 93 and 94 enclosed by a coveraccording to an example of the present technology;

FIGS. 96, 97, and 98 show a PAP device according to an example of thepresent technology;

FIG. 99 shows the PAP device of FIGS. 96 to 98 enclosed by a coveraccording to an example of the present technology;

FIG. 100 shows a PAP device according to an example of the presenttechnology;

FIGS. 101 and 102 show the PAP device of FIG. 100 enclosed by coverportions according to an example of the present technology;

FIG. 103 is a schematic view of a bladder for a blower according to anexample of the present technology;

FIG. 104 is a schematic view of a suspension device for a bloweraccording to an example of the present technology;

FIG. 105 is a schematic view of a printed circuit board according to anexample of the present technology;

FIGS. 106 to 125 show a PAP system according to another example of thepresent technology;

FIG. 126 shows a PAP device enclosed by a cover according to an exampleof the present technology;

FIGS. 127 and 128 show the PAP device of FIG. 126 removed from the coveraccording to an example of the present technology;

FIGS. 129 and 130 show a PAP system including a user interface accordingto an example of the present technology;

FIGS. 131 to 134 show a PAP system including a user interface accordingto another example of the present technology;

FIGS. 135 to 138 show a PAP system including a user interface accordingto another example of the present technology;

FIGS. 139 and 140 show a PAP device including alternative display sizesaccording to alternative examples of the present technology;

FIGS. 141-1 to 141-3 show a PAP device with a non-numeric display thatchanges color/intensity according to an example of the presenttechnology;

FIGS. 142-1 and 142-2 show a PAP device with a non-numeric displayincluding a bar graph according to an example of the present technology;

FIG. 143 shows a PAP device with a non-numeric display including a piechart according to an example of the present technology;

FIG. 144 shows a display including a black resin layer, a clear resinlayer, and an IMD layer according to an example of the presenttechnology;

FIGS. 145-1 to 145-3 show a PAP system with a cover according to anexample of the present technology;

FIGS. 146-1 to 146-2 show a PAP system with a cover according to anexample of the present technology;

FIGS. 147-1 to 147-3 show a PAP system with a cover according to anexample of the present technology;

FIGS. 148-1 to 148-3 show alternative examples for assembling the PAPdevice and tubing into the cover of the PAP system;

FIG. 149 is a schematic view showing an exemplary technique formanufacturing a cover according to an example of the present technology;

FIG. 150 shows a PAP system with a cover according to an example of thepresent technology;

FIG. 151 shows a PAP system with a cover according to an example of thepresent technology;

FIGS. 152-1 to 152-3 show a PAP system with a cover according to anotherexample of the present technology;

FIGS. 153-1 to 153-3 show a PAP system with a cover according to anotherexample of the present technology;

FIGS. 154-1 to 154-3 show a PAP system with a cover according to anotherexample of the present technology;

FIGS. 155-1 to 155-3 show a PAP system with a cover according to anotherexample of the present technology;

FIG. 156 shows an outer casing for a PAP device according to an exampleof the present technology;

FIG. 157 shows an outer casing for a PAP device according to anotherexample of the present technology;

FIG. 158 shows an outer casing for a PAP device according to anotherexample of the present technology;

FIG. 159 shows a PAP system with a cover according to another example ofthe present technology;

FIG. 160 shows a PAP system with a cover according to another example ofthe present technology;

FIG. 161 shows a PAP system with a cover according to another example ofthe present technology;

FIG. 162 shows a PAP system with a cover according to another example ofthe present technology;

FIG. 163 shows a PAP system with a cover according to another example ofthe present technology;

FIG. 164 is a schematic view of air delivery tubing including a tubecoupler according to an example of the present technology;

FIG. 165 is a perspective view of air delivery tubing including a tubecoupler according to an example of the present technology;

FIG. 166 is a cross-sectional view of the air delivery tubing of FIG.165;

FIG. 167 is a side view of the air delivery tubing of FIG. 165;

FIG. 168 is a cross-sectional view of the air delivery tubing of FIG.167;

FIG. 169 is a cross-sectional view of a tube coupler according to anexample of the present technology;

FIG. 170 is a perspective view of air delivery tubing including a tubecoupler according to an example of the present technology;

FIG. 171 is a perspective view of a PAP device and air delivery tubingincluding a tube coupler according to an example of the presenttechnology;

FIG. 172 shows a rigidizer for a patient interface according to anexample of the present technology;

FIGS. 173 and 174 show a rigidizer for a patient interface according toanother example of the present technology;

FIG. 175 shows a rigidizer for a patient interface according to anotherexample of the present technology;

FIG. 176 shows a rigidizer and cushion for a patient interface accordingto another example of the present technology;

FIGS. 177 and 178 show a rigidizer and cushion for a patient interfaceaccording to another example of the present technology;

FIG. 179 shows a rigidizer and cushion for a patient interface accordingto another example of the present technology;

FIGS. 180-182 show various views of a PAP system according to an exampleof the present technology;

FIGS. 183-189 show various views of a PAP system according to an exampleof the present technology;

FIGS. 190 and 191 show back and front views of headgear according to anexample of the present technology;

FIG. 192 is a schematic view of a system including an active tube orsmart tube according to an example of the present technology;

FIG. 193-1 is an enlarged schematic view of active elements of an activetube or smart tube according to an example of the present technology;

FIGS. 193-2 and 193-3 are schematic views of an active tube or smarttube in contracted and extended positions according to an example of thepresent technology;

FIG. 194 is a schematic view showing an active tube, patient interface,and interface controller according to an example of the presenttechnology;

FIGS. 195-1 to 195-4 show schematic views of a system adjusting thetotal force applied to the patient's face by the patient interface inresponse to leak or patient discomfort according to an example of thepresent technology;

FIGS. 196-1 to 196-4 show schematic views of a system adjusting theforce angle applied to the patient's face by the patient interface inresponse to leak or patient discomfort according to an example of thepresent technology;

FIGS. 197-1 to 197-3 show schematic views of a system including apatient interface structured to automatically locate the patient's faceand fit itself after the patient falls asleep according to an example ofthe present technology;

FIG. 198 is a schematic view of a system according to another example ofthe present technology;

FIG. 199 is a schematic view of a system according to another example ofthe present technology;

FIG. 200 is a schematic view of a system according to another example ofthe present technology;

FIG. 201 is a graph showing duration of use for determining anevaluation result according to an example of the present technology; and

FIG. 202 is a graph showing noise free duration for determining anevaluation result according to an example of the present technology.

DETAILED DESCRIPTION OF ILLUSTRATED EXAMPLES

The following description is provided in relation to several examples(most of which are illustrated, some of which may not be) which mayshare common characteristics and features. It is to be understood thatone or more features of any one example may be combinable with one ormore features of the other examples. In addition, any single feature orcombination of features in any example or examples may constitutepatentable subject matter.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen.

The term “wearable” will be taken to refer to a system that is portable,lightweight and/or small to consequently allow the user to move aroundwhile wearing the system.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

1. PAP System

A PAP system typically includes a PAP device (including a blower forgenerating air at positive pressure), an air delivery conduit (alsoreferred to as a tube or tubing), and a patient interface (e.g., mask).In use, the PAP device generates a supply of pressurized air (e.g., 2-30cm H₂O) that is delivered to the patient interface via the air deliveryconduit. The patient interface or mask may have suitable configurationsas is known in the art, e.g., full-face mask, nasal mask, oro-nasalmask, mouth mask, nozzles, nasal prongs, nasal pillows, cannula, nasalcradle, etc. Also, headgear may be utilized to comfortably support thepatient interface in a desired position on the patient's face.

Certain examples relate to PAP systems in which the PAP device or bloweris adapted to be worn on the patient's head, is built into orincorporated into the patient interface or mask, is wearable or carriedby the patient, is portable, is reduced in size or combinations thereof.In certain examples, the PAP system may be of the type described in PCTApplication Nos. PCT/AU2010/001031 and/or PCT/AU2010/001106, each ofwhich is incorporated herein by reference in their entirety.

In an example, the PAP system is intended to be worn during sleep as asingle patient use device to provide relief for snoring disordersassociated with reduced airflow. The PAP system decreases airwayresistance and increases airflow through the nasal passages.

In an example, the PAP system may be structured to deliver pressurizedgas at a pressure of about 6 cmH₂O (e.g., this may be the maximumpressure) at 60 lpm at mask, constant flow. In an example, the PAPsystem may include 90-260 Volts Alternating Current (VAC), 50-60 Hzmains input power, power cord/plug selected to source. In an example,the target audible noise level may be comparable to standard CPAPsystems. In an example, the PAP system appearance may be sleek andnon-medical, unlike a traditional CPAP system. In an example, the PAPsystem may provide simple and intuitive use and connections thatincorporate a single ON/OFF switch. In an example, the PAP system mayprovide a patient interface or mask that is easy to fit and preventsleak without any special training.

2. Exemplary Headworn PAP System Loop Example

FIGS. 1 to 6 illustrate a headworn PAP system 10 including a PAP device20 (also referred to as a flow generator or blower), a patient interface30 (e.g., nozzles, pillows, prongs, or nasal cushion arrangement), andair delivery tubing 40 (e.g., one or more tubes or inlet conduits) thatinterconnect the patient interface and the PAP device. A cover 50substantially encloses one or more portions of the PAP device, patientinterface, and air delivery tubing to secure such components in positionon the patient's head in use. In an example, the components may beeasily disassembled, e.g., for cleaning, replacement, etc.

As illustrated, the PAP system defines a loop that passes generallyalong an underside of the patient's nose, along the cheek region, abovethe ears, and over the crown and parietal portion of the patient's headso as to stabilize the PAP system on the patient's head and providesealing forces against the patient's nose. In an alternative example,the loop may pass below the patient's ears and then over the crown andparietal portion of the patient's head.

2.1 PAP Device

The PAP device 20 is supported within the cover 50 so it sits on top ofthe patient's head in use, e.g., supported on the crown and/or parietalportion of the patient's head. As shown in FIG. 5, such positioning doesnot obstruct the inlet or air intake of the PAP device (e.g., providedalong a top portion of the PAP device) in use, i.e., air intake isunrestricted regardless of the sleeping position of the patient, e.g.,lying on back or his/her side. Each side of the PAP device 20 includesan outlet or outlet opening 21 (e.g., see FIG. 4) structured tocommunicate with a respective air delivery tube such that the PAP devicedelivers air along both sides of the patient's head in use. As shown inFIG. 6, one or more controls 60 for the system (e.g., controls for PAPdevice) may be provided on the top of the patient's head, e.g., for easyaccess by the patient and/or health care professional.

As illustrated (e.g., see FIG. 4), the outer casing of the PAP devicemay be suitably contoured and configured to substantially match thecontours of the patient's head, e.g., for comfort, less obtrusive, lowimpact, low profile, etc.

2.2 Patient Interface

In the illustrated example, the patient interface 30 may include anozzle, nasal prong, pillows, or cushion arrangement (e.g., constructedof silicone) including nozzles, nasal prongs, pillows, or cushion 31adapted to form a seal with the patient's nares. Each side of the nozzlearrangement includes an inlet or inlet opening 32 structured tocommunicate with a respective air delivery tube. The nozzle arrangementmay include a vent 33 to allow the exhalation of gases from the patientinterface and patient.

While the illustrated patient interface is of the nozzle type, it shouldbe appreciated that such interface type is merely exemplary, and otherinterfaces are possible, e.g., nasal mask, full-face mask, mouth mask,under-the-nose interface, etc. In addition, the patient interface may beconstructed of other suitable materials, e.g., silicone, foam, gel,textile, etc. In an example, the patient interface may include a“flower” type interface as described in WO 2010/139014, which isincorporated herein by reference in its entirety.

2.3 Air Delivery Tubing

Each air delivery tube 40 includes a first end configured to connect toa respective outlet of the PAP device 20 and a second end configured toconnect to a respective inlet of the patient interface 30. In use, thetubes are supplied with pressurized breathable gas from the PAP device,and the pressurized breathable gas is delivered into opposing ends ofthe interface.

As shown in FIG. 3A, each tube 40 may have a non-cylindricalcross-sectional shape structured such that it may move between twophases, i.e., a first open phase (FIG. 3A) and a second at leastpartially collapsed phase (FIG. 3B) in which the tube is at leastpartially collapsed and comfortable to lie on. In the second at leastpartially collapsed phase (FIG. 3B), opposing walls of the tube mayengage one another at one or more points or surfaces along their lengthsuch that conductance through the at least partially collapsed tube maybe minimized. Each tube is structured to handle full pressure in use.Further examples of such tubing are disclosed in U.S. Publication NoUS-2008-0060649, which is incorporated herein by reference in itsentirety.

It is preferred that two tubes be used, so that a sufficient supply ofbreathable gas can still be delivered to the patient interface when oneof the tubes is at least partially collapsed, e.g., due to the patientlying on his/her side. That is, when two tubes are used, one or both ofthe tubes may be open in use. However, it should be appreciated that asingle tube or more than two tubes may be used, e.g., three or moretubes.

2.4 Cover

One or more portions of the cover 50 may be constructed of a textilematerial, e.g., breathable fabric to reduce perception of heat anddemonstrate performance.

One or more portions of the cover 50 may include a clear portion orwindow/opening, e.g., to show the patient's face and reveal technology.For example, the cover may include clear portions 50(1), 50(2) to exposeportions of the seal of the patient interface and air delivery tubingand an opening 50(3) to expose the vent of the patient interface.

One or more portions of the cover may have different colors (colorcontrast), patterns, and/or surface texture. For example, a bluepinstripe may be provided along the cover to provide a performanceelement that shows air flow. Also, a hang tag may be provided to thecover to provide apparel aesthetic and soft brand treatment. Inaddition, the cover may include a two-tone color scheme to reduce visualthickness or provide orientation, e.g., distinct inside and outsidesurfaces.

Further examples of covers are disclosed in U.S. Publication No.US-2008-0047560, which is incorporated herein by reference in itsentirety.

In an example, the cover may be formed in one piece (e.g., co-molded)with the air delivery tubing. In an example, the cover may constitute orotherwise provide the air delivery path from the PAP device to thepatient interface, i.e., textile-type tubing in lieu of silicone-typeair delivery tubing.

3. Exemplary PAP System Pillow Example

FIGS. 7 to 12 illustrate a PAP system 210 according to another exampleof the disclosed technology. In this example, the PAP system includes aPAP device 220 adapted to be positioned in, under, or adjacent thepatient's pillow in use, a patient interface 230 (e.g., nozzle/nasalprong arrangement), and air delivery tubing 240 (e.g., outlet tube240(1) that bifurcates into two inlet tubes 240(2)) that interconnectthe patient interface and the flow generator. Headgear including asingle generally circular strap 270 (e.g., crown strap portion 270(1)and back strap portion 270(2)) is provided to stabilize and support thepatient interface and inlet tubes on the patient's head. The singlegenerally circular strap simplifies taking the PAP system on and off thepatient's head. A cover 250 substantially encloses one or more portionsof the PAP device 220 and the outlet tube 240(1) of the air deliverytubing. In an example, the components may be easily disassembled, e.g.,for cleaning, replacement, etc.

The patient interface and inlet tubes may define a loop that passesgenerally along an underside of the patient's nose, along the cheekregion, above the ears, and over the crown of the patient's head. Thesystem provides seamless transitions, i.e., simple flowing shape isminimal and appears wearable, so overall perception is improved (notlike medical plumbing). Also, the system provides an aesthetic which istransparent about the air sensation provided by the system. In analternative example, the tubes may pass below the patient's ears andthen over the crown of the patient's head.

In this example, the patient interface, inlet tubes, and headgear may beconstructed of materials including different colors, patterns, and/orsurface texture so as to blend in with the patient's skin and hair(e.g., “disappearing” materials). For example, the patient interface andinlet tubes may be constructed of a substantially transparent material(e.g., silicone) such that it is transparent or blends in with thepatient's face. The headgear (generally circular strap) may beconstructed of a material to blend in with the patient's hair, e.g.,warm grey fabric which is disguised by the patient's hair. It should beappreciated that the materials may be suitably selected for differentusers.

3.1 PAP Device

As best shown in FIGS. 9 and 10, the PAP device 220 is located withinthe cover 250 and adapted to be positioned under or adjacent thepatient's pillow in use. The PAP device provides a substantially lowprofile so it is not obtrusive and does not significantly affect thepatient's sleeping position.

The PAP device may include an extended feature for drawing air throughthe inlet or air intake of the PAP device in use (e.g., see FIG. 45embodiment). The extended feature may include an elongated inlet or airintake (not shown) having a first end attached to the inlet of the PAPdevice 220 and a second end adapted to be positioned to receive air fromthe surroundings. The second end of the elongated inlet or air intakemay also have an inlet filter 527 to remove particulates. In an example,the elongated inlet or air intake and the air delivery tubing may run inparallel directions or alternatively in different directions.

The PAP device includes an outlet or outlet opening 221 structured tocommunicate with the outlet tube 240(1) of the air delivery tubing(e.g., see FIGS. 11 and 12).

As shown in FIG. 12, a Hi/Low pressure control/toggle 260 may be locatedon the PAP device. It should be appreciated that additional controls forthe system may be provided to the PAP device.

3.2 Patient Interface

In the illustrated example, the patient interface 230 includes anozzle/nasal prong arrangement as described above (e.g., see FIG. 11).However, other suitable interfaces are possible, e.g., nasal mask,full-face mask, mouth mask, under-the-nose interface, etc.

3.3 Air Delivery Tubing

In the illustrated example, the air delivery tubing 240 includes anoutlet tube 240(1) having two tubes joined together (e.g., see FIG. 9A)at the outlet of the PAP device (e.g., both tubes adapted to be coupledto a single outlet of the PAP device), and then the tubes bifurcate(i.e., split or divide into separated inlet tubes 240(2)) towardsrespective ends of the patient interface.

As described above, the inlet tubes 240(2) may have a non-cylindricalcross-sectional shape structured such that it may move between open andat least partially collapsed phases. In addition, the cross-sectionshape includes a blending contour that is smooth, streamlined, sleek,and blends or tapers the tubes with or into the contours of thepatient's head (not like standard medical plumbing or tubing).

In an example as best shown in FIG. 12, a quick disconnect 280 may beprovided between the inlet tubes 240(2) and the outlet tube 240(1)extending from the PAP device, e.g., to allow the patient to get upduring the night without having to remove the entire patient interface.In an example, an On/Off control 281 may be provided or coupled to thequick disconnect 280, e.g., to easily turn off the PAP device whenarising.

3.4 Cover

As shown in FIG. 11, the cover 250 includes a pouch portion 251 tosubstantially enclose one or more portions of the PAP device 220 and atube portion 252 to substantially enclose one or more portions of theoutlet tube 240(1).

4. Exemplary PAP System Wrap Example

FIGS. 13-18 illustrate a PAP system 310 according to another example ofthe disclosed technology. In this example, the PAP system 310 includes aPAP device 320, a patient interface 330 (e.g., nozzle/nasalprong/cushion arrangement), and air delivery tubing 340 to interconnectthe patient interface and the flow generator. A cover 350 substantiallyencloses one or more portions of the PAP device and the air deliverytubing. In addition, the cover includes a headgear strap portion 355that cooperates with another headgear strap 370 to wrap around thepatient's head to stabilize and support the system on the patient'shead. In an example, the components may be easily disassembled, e.g.,for cleaning, replacement, etc. Also, the system provides humanasymmetry, which may help to eliminate “face widening” effect, and showorientation.

4.1 PAP Device

The PAP device 320 is supported within the cover 350. In an example, asshown in FIG. 16, the PAP device 320 may extend out of the end of thecover to allow access to one or more controls 360 provided to the PAPdevice.

When the patient is standing as shown in FIG. 14, the PAP device may besuspended from the patient's head by the tubing so it is positionedadjacent to and/or supported by the patient's shoulder. When the patientis lying in bed as shown in FIG. 15, the PAP device may be positionedadjacent the patient's head (e.g., on, under or adjacent the patient'spillow). The PAP system 310 is illustrated as being configured to wrapacross to the left side of a patient's body or face. However, it is tobe understood that the PAP system 310 may also be configured to wrapacross to the right side of a patient's body or face.

The PAP device 320 includes an outlet or outlet opening 321 structuredto communicate with the air delivery tubing 340 (e.g., see FIG. 18). Asshown in FIG. 15, the suspended arrangement of the PAP device from thepatient's head allows for a flexible sleeping position, e.g., PAP devicemay be pivoted 180° with respect to the patient's head.

4.2 Patient Interface

In the illustrated example, the patient interface 330 includes anozzle/nasal prong arrangement (e.g., constructed of silicone) includingnozzles/nasal prongs adapted to form a seal with the patient's nares(e.g., see FIG. 18). In this example, only one side of the nozzlearrangement includes an inlet or inlet opening 332 structured tocommunicate with the air delivery tubing. The nozzle arrangement mayinclude a vent to allow the exhalation of gases from the patientinterface and patient. However, other suitable interfaces and interfacearrangements are possible, e.g., nasal mask, full-face mask, mouth mask,under-the-nose interface, etc.

4.3 Air Delivery Tubing

In the illustrated example, the air delivery tubing 340 includes asingle tube supported within the cover 350 and connected between theoutlet of the PAP device and the inlet of the nozzle arrangement. Asshown in FIGS. 13 to 15, the covered tube wraps around the patient'shead, e.g., like a scarf.

4.4 Cover

As best shown in FIGS. 14 and 18, the cover 350 includes a pouch portion351 to substantially enclose one or more portions of the PAP device, atube portion 352 to substantially enclose one or more portions of theair delivery tube, and a headgear strap portion 355 that cooperates withanother headgear strap to wrap around the patient's head to stabilizeand support the system on the patient's head.

The headgear strap portion 355 is structured to wrap along the cheekregion, above the ears, and around the back of the patient's head, andconnect to an intermediate portion of the headgear strap 370 (e.g.,headgear strap includes loop that allows headgear strap portion to wraptherearound) so as to define a back strap for supporting the system. Theheadgear strap 370 is structured to wrap under the patient's nose, alongthe cheek region, above the ears, and over the crown of the patient'shead, and connect to an intermediate portion of the headgear strapportion 355 (e.g., headgear strap portion includes loop that allowsheadgear strap to wrap therearound) so as to define a crown strap forsupporting the system. In an alternative example, the strap may passbelow the patient's ears and then over the crown of the patient's head.

The headgear strap portion 355 and headgear strap 370 overlap by thepatient's nose. The headgear strap portion and headgear strap may beconnected to one another at the overlap, e.g., by a button 375 (e.g.,reminiscent of a beauty mark), which may also serve as a vent from thepatient interface (e.g., see FIGS. 13 and 15). The overlapped connectionmay reduce visual weight in the nose area.

One or more portions of the cover 350 may be constructed of a textilematerial, e.g., bedroom-like fabrics, which may connect the system withthe environment and contribute to overall approachability and comfort.Also, as shown in FIG. 17, the headgear strap portion 355 and headgearstrap 370 may include a two-tone color arrangement to provide quick-readorientation. The two-tone color arrangement may minimize the appearanceand size of the device as well as indicate which side of the devicefaces the patient, e.g., see FIGS. 106-125.

5. Controls and Feedback Examples

The following provides alternative examples of controls and feedback forPAP systems including for use with any one of the exemplary PAP systemsdescribed herein.

5.1 Basic Controls, No Feedback

In an example, the PAP system may include basic controls to keep costslow, but such basic controls may provide little if any feedback to thepatient.

FIG. 12 illustrates an example of a PAP system with basic controls,e.g., a Hi/Low pressure control/toggle 260 located on the PAP device 220and an On/Off control 281 provided to the quick disconnect 280 of theair delivery tubing. The PAP device may also include an automatic rampfeature, an overheating motor shut-off, and/or a motor overheat LEDindicator.

5.2 Basic Controls, Comprehensive Feedback Online

In an example, the PAP system may include basic controls withcomprehensive feedback provided to the patient online. The basiccontrols on the PAP device keep daily use simple, and comprehensiveinformation online keeps the patient engaged.

FIG. 6 illustrates an example of a PAP system with basic controls, e.g.,Hi/Low pressure control/toggle 61 and On/Off control/button 60 providedto PAP device 20. The PAP device may also include electronics to monitorand collect relevant data, a USB stick 65 to transfer data, an automaticramp feature, an overheating motor shut-off, and/or a motor overheat LEDindicator. Also, online service may be provided to track and providefeedback to the patient.

5.3 Basic Controls, Essential Feedback on PAP Device

In an example, the PAP system may include basic controls with essentialfeedback provided on the PAP device, e.g., via graphical displayprovided to the PAP device. The simple controls and graphical feedbackhelp the patient understand the therapy and stay motivated.

FIG. 16 illustrates an example of a PAP system with basic controls,e.g., controls 360 providing Hi/Low pressure control/toggle and On/Offcontrol/button provided to PAP device 320. The PAP device may alsoinclude electronics to monitor and collect relevant data, low resolutionbacklit Liquid Crystal Display (LCD) to display feedback, and/oroverheating motor shut-off. Additional controls or settings may includea wake-up alarm (e.g., wakes with breathing pattern).

6. Additional Examples of PAP Systems

FIGS. 19-42 illustrate additional examples of PAP systems, includingadditional examples for wrapping headgear straps and/or covers aroundthe patient's head, supporting the PAP device on or adjacent thepatient's head, covering the patient's faces with bandana-like covers,and/or directing air delivery tubing along the patient's head. One ormore examples may be configured in view of heat comfort, ease of puttingon/off, strap size and location, proportion, and/or part break. Inaddition, one or more examples may be configured in view of materialqualities, color, details, human proportion, visual size, and/or genderneutrality.

FIGS. 19, 29 and 30 illustrate PAP systems having a bandana typearrangement such that a material cover 3001 is located over the patientinterface to shield, protect or conceal a patient's nose and mouth andthe patient interface. Different lengths of the material cover 3001 maybe provided as indicated in FIGS. 19, 29 and 30. FIG. 19 shows thearrangement of the material cover 3001 when a patient is upright andFIGS. 29 and 30 show the arrangement of the material cover 3001 when apatient is lying down.

FIGS. 20, 21 and 37 show different examples of a textile cover 3101 thatis configured to cover and wrap into the headgear. FIG. 20 shows a closefitting textile cover 3101 and FIGS. 21 and 37 show looser textilecovers 3101. The air delivery tube runs within the textile cover. Thisarrangement assists in disguising the medical looking features of thesystem and makes the system appear as an all one unit rather thanmultiple components joined together. The button 3101-1 on the textilecover may assist with providing a non-medical or softer look and feel ofthe system. The button may also comprise both the vent for the patientinterface and the attachment mechanism for the patient interface. FIG.26 illustrates the arrangement of the textile cover 3101 when thepatient in lying down. The air delivery tube, patient interface and PAPsystem are all located within the textile cover to provide theappearance of a single complete system.

FIGS. 22 and 28 illustrate an example with the PAP device 3201 locatedon a top portion of a patient's head. The PAP device, patient interfaceand air delivery tube are each located within or under a cover to givean overall look of an all-in-one or complete single system. The covermay also reduce the medical look of the system and/or hide, veil orconceal the connection points between the different components of thesystem, such as the patient interface, air delivery tubing and PAPdevice connection points. The patient interface may include nasalpillows, a nasal cradle, nasal prongs or a nasal cushion. FIG. 27illustrates a similar example with the PAP device located on top of thepatient's head and including a nasal cannula as the patient interface.

FIG. 23 illustrates another head worn arrangement wherein the PAP deviceand cover 3301 are wrapped around the forehead rather than on top of thehead.

FIG. 24 illustrates an exemplary PAP system wherein the PAP device 3401is configured to swing or suspend from the head and may rest against thechest when the patient is in the supine position. The air deliverytubing is located within the textile cover 3402 that wraps around thetop of the head and connects to the patient interface strap 3403 wrappedacross the face.

FIG. 25 illustrates a similar PAP system arrangement to that shown inFIGS. 9-10, with a slightly different headgear strap arrangement. Theheadgear strap portion 3501 is structured to wrap along the cheek regionand up over the top of the patient's head and also include a supportingstrap 3502 structured to wrap below the ears, and around the back of thepatient's head or neck region.

FIG. 31 illustrates a PAP system arrangement having a wrap arrangement3601 configured to provide predominantly under-the-ear vectors tosupport the patient interface and air delivery tubing that are supportedin or under a textile cover. Further headgear straps 3602 that extendover the top of the head assist in supporting or holding the interfaceup against the patient's face or nose.

FIG. 32 illustrates a PAP system arrangement including a headgear strap3701 that is structured to wrap across the face above the upper lip andbelow the nose and under the patient's ears to support the patientinterface against the face. A further strap 3702 extends over the earsto assist in maintaining and sealing the patient interface in positionagainst the nasal region.

FIG. 33 illustrates a PAP system arrangement wherein the air flow isrouted through an air delivery tube or conduit 3801 located within theheadgear system.

FIGS. 34 and 35 illustrate PAP system arrangements having a PAP device3901 positioned on or in a strap across the patient's forehead or in aforehead support. As shown in FIG. 34, the PAP system may include aninlet filter 3901-1 on the front of the device to provide clean air.Such an arrangement may also be suitable for providing purified air totreat conditions such as asthma, allergies, etc. Alternatively, a brandor logo 3901-2 may be printed on the front of the device as indicated inFIG. 35. The patient interface may also include a vent on the outersurface.

FIG. 36 illustrates an example of a forehead strap 4001 positionedacross the patient's forehead to provide support for a PAP devicelocated at the back of the head. The forehead strap also supports sideand top straps in position to assist in maintaining the patientinterface in position against the patient's face or nose.

FIGS. 38, 39 and 40 illustrate PAP system arrangements having airdelivery tubing 4101 coupled to the patient interface and arrangedwithin the headgear straps. The length of the patient interface portionand where it connects to the air delivery tubing in the headgear differsbetween these different arrangements. FIG. 40 shows a small patientinterface portion 4102 that is predominately located under the nose.FIG. 39 shows a slightly larger patient interface portion 4102 thatextend across the cheek region prior to coupling to the air deliverytubing. FIG. 38 shows a large patient interface portion 4102 thatextends up adjacent the ear region prior to coupling to the air deliverytubing. As shown in FIG. 40, a clear window 4102-1 may be provided atthe front of the patient interface portion to allow visibility of thenostrils when in use.

FIG. 41 illustrates a PAP system arrangement having a head band strap4201 that is configured to support the air delivery tubing 4202, e.g.,by having strap portion to hold a portion of the air delivery tube onthe head band to assist in maintain the system in position on the headand face.

FIG. 42 illustrates a PAP system arrangement having a PAP system locatedwithin a cover 4301 on the head and air delivery conduits are locatedwithin a cover together with the PAP device. A clear window 4302 may beprovided under the patient interface to allow visibility of the nasalregion.

It is noted that all of the examples described above may be formed of aclear silicone, elastomeric material to allow visibility and appear lessvisible on the face. Alternatively, each of the examples may be formedfrom a textile material or a combination of a textile material toprovide a less medical and less obtrusive look as described in moredetail herein.

In an example, the positioning of the PAP device relative to thepatient's head may at least partially determine a size of the airdelivery tube. For example, an increased distance of the PAP device fromthe patient's nose may result in an increased diameter of the airdelivery tube. In an example, a PAP device positioned about 50 cm to 80cm, such as 60 cm or 70 cm, from the patient's nose (e.g., maximumdistance) will result in an air delivery tube having a diameter of about10 mm to 20 mm, such as 15 mm.

As shown in FIG. 43, a PAP device positioned in Zone A may be preferredfor comfort and functioning of the PAP device. Zone B may be morepreferable than Zone C to provide a smaller system with a reduced tubediameter.

7. Alternative Examples

The following provides alternative examples of wearable PAP systems.

7.1 Flow Generator Appears Invisible

In an example, a video camera or image recording device may be attachedor otherwise provided to a first side of the PAP device, and a screen oroutput device may be provided on another side of the PAP device. Theimage recording device may record the image that is directly in front ofit, and display the recorded image on the output device. In an example,the output device is provided on an opposite side of the PAP device tothe image recording device.

For example, the image recording device may be pointed or directed tothe wall, which results in the output device displaying an image of thewall. This display may allow the PAP device to appear more invisible asthe patient will only see an image of the wall.

7.2 Small PAP Device without a Motor

In an example, air may be pressurized by electrically stimulating theair.

For example, a textile conduit may be electrically stimulated to pulse,or relax and contract (similar motion to peristalsis), so it is like atextile muscle. By varying the diameter of the conduit, it will forceair to travel towards a patient end of the conduit and pressurize theair. The textile conduit may also include one or more valves that mayperiodically open and close to aid in the buildup of pressure.

In an example, a pair of pistons may be positioned at each nostrilwithin a cylinder, each piston driven by a drive structure (e.g.,connecting rod and crank) to cause the piston to move up and down. Asthe pistons move up they force air into the patient's nose. The speed ofthe piston will dictate the pressure delivered to the patient's nose.Each piston may be connected such that as one piston moves up and forcesair into the patient's airways, the other piston retracts and thecylinder refills with air. Alternatively, the pistons may not beconnected and run either in sync or out of sync.

7.3 Small PAP Device with a Motor

As shown in FIG. 44, an impeller 490 may be provided to the patientinterface or mask 430 which is driven by a motor 495 (e.g., batterypowered) coupled to the impeller 490 by a twist drive or snake drive497, i.e., cable-like drive shaft.

7.4 “Smart” Tube

In an example, the air delivery tube may be configured to follow themovements of the patient in use, i.e., smart tube. For, example, thetube may include one or more sensors configured to sense movement of thepatient and an adjustment device configured to automatically adjust theposition of the tube to compliment the patient's position. In anotherexample, one or more magnets or electromagnets or other means ofattraction may be used to allow the tube to follow movements of thepatient, e.g., magnets embedded in the patient's bed clothes.

FIG. 192 is a schematic view of a system 2500 according to an example ofthe technology. The system is structured to automatically position thepatient interface optimally for the patient, and sense and respond tothe patient in order to improve the overall sleep and therapy deliveryexperience for the patient. The system includes an active tube or smarttube structured to provide a force to the patient interface so as topush or seal the patient interface onto the patient's face, therebyperforming the function of headgear. In examples, headgear is notprovided or needed in the system although may be optionally provided toenhance stability and/or positioning of the patient interface. Removalof the headgear may reduce claustrophobia through removal of headgearsurface area and forces on the patient's head.

The system looks and feels invisible to the user in that it performs thefunction of the headgear. In an example, the system may be structured toautomatically fit the patient interface to the patient after the patientis asleep.

As illustrated, the system 2500 includes a base unit 2501 (including ablower for generating air at positive pressure), a patient interface2502 adapted to engage the patient's face, and an active tube or smarttube 2503 to deliver the supply of pressurized air (e.g., 2-30 cm H₂O)to the patient interface and to create the correct interface force andangle to the patient's face. The patient interface or mask may have anysuitable configuration as is known in the art, e.g., full-face mask,nasal mask, oro-nasal mask, mouth mask, nozzles, nasal prongs, nasalpillows, cannula, nasal cradle, etc. In an alternative example, thepatient interface may be positioned adjacent to or near the patient'sface and not specifically engaged. This arrangement may be provided, forexample, to deliver treated air that has medical or health-givingbenefits, e.g., purified air, air containing antioxidants or medication.

The active tube 2503 is structured such that it can modify its own shapein order to move the patient interface, modify the amount of forceexerted between the patient interface and the patient and/or move/adjustits own positioning. In an example, as shown in FIG. 193-1, the activetube 2503 may include a series of active elements 2503-1 to adjust thelength of the tube 2503-2. As illustrated, each active element 2503-1includes at least one side that may be selectively contracted and/orextended in order to adjust the length of the tube. For example, asshown in FIGS. 193-1 and 193-2, one or both sides of selected activeelements 2503-1 may be contracted in order to bend and hence shorten thelength of the tube. Alternatively, one or both sides of selected activeelements 2503-1 may be extended in order to straighten and hence extendthe length of the tube as shown in FIG. 193-3. Suchbending/straightening of the tube adjusts the lateral undulation andhence length of the tube, which adjusts the force provided to thepatient's face by the patient interface provided to the end of the tube.For example, selective active elements may be contracted to shorten thelateral extent of the tube and hence reduce or relieve force provided tothe patient's face, and likewise selective active elements may beextended to extend the lateral extent of the tube and hence increase orenhance force provided to the patient's face. The differentialcontraction or extension across the active elements may be achieved bypiezo actuators for example, or by other suitable means. In certainarrangements, the force provided to the patient's face may beautomatically adjusted based on a detected level of leak from thepatient interface.

However, the length or shape of the tube may be modified in othersuitable manners. For example, the length of the tube may be varied bylinear motion, rather than differential bending of an S-like form asdescribed above. FIG. 199 illustrates an example of a system 2700including a base unit 2701, a patient interface 2702, and an active tube2703 having a combination of straight or curved elements 2703-1 withpivots 2703-2 at their junctions. FIG. 200 illustrates an example of asystem 2800 including a base unit 2801, a patient interface 2802, and anactive tube 2803 having a combination of a large rigid element 2803-1and a shorter selectively adjustable element 2803-2 similar to theactive tube 2503 described above. In this arrangement, the element2803-1 provides larger adjustments while element 2803-2 provides finetuning, smaller adjustments.

The base unit 2501 provides a fixing point or base from which one end ofthe active tube is anchored for applying force to the patient via thepatient interface. The base unit may be immovable via the use of mass,friction, attachment to a relatively stable object compared to thepatient or to the patient's body, e.g., dead weight, clip to headboardof bed, etc. In an example, the base unit may be attached to thepatient's body.

An interface controller 2504 is provided to the patient interface 2502to adjust the angle of the patient interface relative to the wearer,using the active tube 2502 as a steady base as shown in FIG. 194. Aforce sensor 2505 is provided adjacent the patient interface to measurethe force and torque between the patient interface and the patient'sface.

A controller or control module 2506 is provided to the base unit tomonitor and control adjustment of the system so that the patientinterface is optimally positioned for the patient for therapy. Thecontrol module receives and processes input signals, analyzes data, andsends commands to the active tube and interface controller. In anexample, signal communication 2508 may be provided by wires integratedinto the active tube or wireless elements, e.g., configured to sendinput signals from the force sensor to the control module, and sendcommands from the control module to the active tube and interfacecontroller.

The control module receives data from the force sensor, data regardingthe positioning of the tube, data regarding the patient's sleepingposition, and/or data regarding the patient's breathing patterns inorder to analyse the patient's activity and positioning and makeadjustments to the patient interface for optimal treatment. At any giventime, the control module knows: the position of the active tube relativeto the base unit and the structural shape of the active tube (e.g., byassessing the position state of each of the active elements (i.e.,contracted or extended) in the tube at any given time; force and torquebetween the patient interface and the patient at the end of the tube(e.g., measured by force sensor 2505); the sleeping position of thepatient (e.g., interpreted from the shape of the tube and the angle ofthe patient interface relative to the tube, visual data by video orinfrared sensing; and/or the breathing patterns of the patient.

In an example, the system may be configured to anticipate what patientmovement is likely to come next, e.g., based on historical data analysisof sleep movement of the patient and the general population. Forexample, the control unit may record patient movement and store thisdata, and therefore build a “profile” of the patient's typical sleepingmovements over a usage period. Over time, this data may be used toprovide feedback to the patient, e.g., information whether any chosenperiod of sleep is typical or unusual, restless or peaceful. Thisprofile data may be related to subjective data entered by the patient.

The control module is configured to recognize needs of the patient andimprove performance of the system by sensing the magnitude of cushionseal force being applied and whether leak is occurring. The controlmodule can use this information, e.g., to reduce force provided by thepatient interface to the patient's face if it is unnecessarily high orto increase force provided by the patient interface to the patient'sface if there is a leak. Further, the angle or force vector provided bythe patient interface can be adjusted to provide an optimum seal/comfortlevel by responding to the location of the leak. In an example, leaklocation data may be provided by the patient interface and/or audiobased leak sensing data. Also, the patient may intentionally set theinterface angle and force to achieve desired effects such as more orless force in a specific region of the patient's face.

The example techniques discussed in preceding paragraphs above may beperformed on or via a PAP or other computer device that includesprocessing resources including at least one processor or controller anda memory. These example techniques also may be implemented in anysuitable combination of hardware, software, firmware, and/or the like.For instance, in software-based or software-inclusive implementations, aprogram or set of instructions, when executed using the processingresources of the PAP or other computer device, may be configured theseand/or other steps to be carried out.

FIGS. 195-1 to 195-4 show an example of the system adjusting the totalforce applied to the patient's face by the patient interface in responseto leak or patient discomfort. For example, FIG. 195-1 shows a leakbetween the patient interface and the patient's face and FIG. 195-2shows the system increasing the force applied to the patient's face(e.g., by modifying the active tube) to stop the leak. Likewise, FIG.195-3 shows a discomfort between the patient interface and the patient'sface and FIG. 195-4 shows the system decreasing the force applied to thepatient's face (e.g., by modifying the active tube) to ease thediscomfort.

FIGS. 196-1 to 196-4 show an example of the system adjusting the forceangle applied to the patient's face by the patient interface in responseto leak or patient discomfort. For example, FIG. 196-1 shows a leakbetween the patient interface and the patient's face and FIG. 196-2shows the system adjusting the angle of the patient interface relativeto the patient's face (e.g., via the interface controller 2504) to stopthe leak. Likewise, FIG. 196-3 shows a discomfort between the patientinterface and the patient's face and FIG. 196-4 shows the systemadjusting the angle of the patient interface relative to the patient'sface (e.g., via the interface controller 2504) to ease the discomfort.

In FIGS. 195-1 to 196-4, the system provides an adaptive system thatallows the patient interface to acquire an optimum fit (by adjustingforce and/or torque) between the patient interface and the patient bymaking real-time changes based on the movement of the user and changesin leak and comfort. Such arrangement improves comfort for the patientby reducing mask force to the minimum required at any point in time(e.g., satisfactory seal and comfort) and responding automatically toleak events.

In an example, the system may allow the patient interface to move inresponse to or anticipation of the patient sleep movements, therebyexerting no tube drag by “following” the patient. For example, thesystem adapts or responds to patient movement by adjusting the forceand/or torque (e.g., by modifying the active tube and/or interfacecontroller) provided by the patient interface to the patient to followthe patient movement for optimal fit and comfort. Such arrangementimproves stability of the patient interface because of reduced tube dragand enables less obtrusive patient interfaces that usually fail due topoor stability.

FIGS. 197-1 to 197-3 show an example in which the system allows thepatient to fall asleep without having to fit the patient interface, andthe patient interface automatically locates the patient's face and fitsitself after a time delay, i.e., system adapted to fit itself to thepatient while the patient is unaware or asleep. For example, FIG. 197-1shows the patient awake with the patient interface disengaged from thepatient, FIG. 197-2 shows the patient asleep with the patient interfacestill disengaged from the patient, and FIG. 197-3 shows the patientinterface automatically located and engaged with patient following atime delay, e.g., predetermined period of time following acknowledgementthat the patient is asleep. Such arrangement allows the patient to fallasleep more naturally, thereby making therapy essentially invisible tothe patient and their bedpartner. Also, such arrangement allows greatercompliance through improved bedtime experience and attractiveness of thesystem to the patient and bedpartner, e.g., allows patient to fallasleep reading a book. In an example, the patient could override theautomated fit system.

In an example, the patient may wear a sticker or marker in a specifiedlocation on the face to allow the patient interface to automaticallylocate the patient's face in use. The marker may alternatively belocated in a simple strap, band, or headgear that is worn by thepatient. The sticker or marker may include a small device configured toemit a signal, emit a magnetic field, and/or display a distinctive shapethat may be identified by a corresponding receiver on the patientinterface. This information may be combined with the shape of the tubeto allow the control module to determine the location of the patient.

Alternatively, the patient could position the interface in the correctposition on the face and record this position by a push button orsimilar method on the base unit. The base unit could monitor subsequentchanges in patient face location via infra-red or similar positionalsensing methods. Once the interface is ready to be moved to the face,the system would compute where to locate the mask, based on thecombination of the initial recorded location, plus any subsequentmovement detected.

In an alternative example, the base unit may not include a blower forgenerating air at positive pressure. For example, as shown in FIG. 198,the system 2600 includes a stable base unit 2601, a patient interface2602, a blower 2610 provided to the patient interface, and an activetube 2603 to move the patient interface/blower to adjust force, angle,and/or positioning of the patient interface/blower. In this example, theactive tube is not a conveyer of pressurized air, but rather apositioning mechanism for the patient interface/blower. An interfacecontroller 2604 and force sensor 2605 as described above may be providedto the patient interface/blower to adjust the angle and measureforce/torque.

7.5 Neck Brace

In an example, a neck brace may be provided to fit around the patient'sneck and to support the patient's chin so as to increase and maintainthe distance between the patient's chin and chest. This arrangementincreases the size of the patient's airway. The neck brace may applyforce to the bony part of the chin or to the softer skin under the chinand closer to the neck (e.g., this may also push the tongue closer tothe front of the mouth).

7.6 Bed Clothes

In an example, one or more portions of the patient's bed clothes may beconstructed of inflatable bladders, such that if an airway obstructionis detected, one or more bladders of the bed clothes may inflate tothereby roll the patient on their side or front to aid in opening thepatient's airway.

7.7 Power for the PAP System

In an example, power for the PAP system may be generated by kineticenergy from the patient's movements during sleep. Alternatively, the PAPsystem may be powered by heat or other chemical reaction from thepatient.

7.8 Magnets

In an example, an impeller driven by magnets may be supported in theframe of the patient interface or mask. The mask frame may have magnetsaround the impeller cage, and the impeller may have opposing magnets onone or more of its impeller blades. The opposing magnetic force betweenthe frame and the impeller may drive the impeller.

7.9 Mini Blowers

In an example, a series of relatively small blowers may be connectedtogether to generate the supply of pressurized breathable gas.

7.10 Compressed Air

In an example, a cooled can of compressed air may deliver sufficientpressurized air to a patient, e.g., for one night. The can may beconnected to a patient interface or mask for therapy delivery.

7.11 Ear Plugs

In an example, ear plugs may be configured to create a pressuredifferential in the patient's ear canal. The ear plugs may trigger thepressure differential if an airway obstruction is detected. This createsa sensation whereby the patient will want their ears to “pop”. This maytrigger the patient to swallow in order to equalize the pressure,thereby opening the airway.

7.12 Distal Inlet for PAP Device

In an example, wearable PAP systems worn on the body (e.g., strappedaround the patient's chest) may be covered by blankets and/or other bedclothes when in use. Accordingly, the PAP device should include an inletthat is distal or remote from the PAP device to ensure such inlet is notobstructed or impeded by the blankets/bed clothes in use.

For example, as shown in FIG. 45, the PAP device may include anelongated inlet tube 525 having a first end 525(1) attached to the inletof the PAP device 520 and a second end 525(2) adapted to be positionedoutside the blankets/bed clothes (e.g., outside of the bed or over theheadboard) to receive air. As illustrated, the second end of the inlettube may have an inlet filter 527 to remove particulates (e.g.,corn-cobb-like filter including multiple relatively little filters in acage-like arrangement, which provides adequate flow if partiallyblocked).

In the illustrated example, the PAP device and inlet tube may beenclosed by a cover or wrap 550, e.g., soft textile. At least a portionof the cover may be diffuse, e.g., portion surrounding the second end525(2) and inlet filter 527 of the inlet tube.

In the illustrated example, the PAP device 520 may include a LCD display560 and one or more control buttons 561, e.g., power button.

In an alternative example, the PAP device may be supported within apocket provided to the patient's bed clothes. For example, one or bothshoulders of the patient's bed clothes may include a pocket.

In an example, the minimum distance between the PAP device (e.g., inlettube) and the patient's head is no longer than a typical necklacelength.

7.13 Blower Behind the Pillow

In an example, as shown in FIGS. 46, 47, and 48, the blower (enclosed bycover portion 650(1)) is positioned above and/or behind the patient'spillow, e.g., behind and at least partially below a central portion ofthe patient's pillow. Such position of the blower may least encumbernatural sleep. For example, this positioning or orientation of theblower keeps the air delivery tubing (enclosed by cover portion 650(2))away from the patient's neck, allows for easy side-to-side turning, andworks best for stomach and back sleepers. The behind-the-pilloworientation also works best for hiding the device, e.g., patients mayprefer to keep or hide the blower under or behind the pillow when not inuse.

In an example, the blower and/or the cover portion enclosing the blowermay include a retaining structure (e.g., clip structure) to maintain theblower in position with respect to the patient's pillow. For example,FIGS. 49-1 to 49-6 illustrate alternative examples for retainingstructures. In FIG. 49-1, the blower 620 includes a resilient clipstructure 690-1 structured to grasp an edge of the pillow to maintainthe blower in position. In FIG. 49-2, the blower 620 includes aresiliently pivotal clip structure 690-2 structured to grasp the edge ofthe pillow. In FIG. 49-3, the blower 620 includes a clip structure 690-3with magnet portions structured to magnetically retain the pillow via amagnet provided to the edge of the pillow. In FIG. 49-4, the blower 620includes a resilient and arcuate-shaped clip structure 690-4 structuredto grasp the edge of the pillow. In FIG. 49-5, the blower 620 includes aover-center clip structure 690-5 to grasp the edge of the pillow. InFIG. 49-6, the blower 620 includes a roller arrangement 690-6 includingupper and lower rollers that cooperate to grasp or bite the edge of thepillow.

In an example, the thickness of the outer casing of the blower or PAPdevice may be relatively thin to enhance comfort when the blower ispositioned under the pillow in use. Also, in an example, the height ofthe outer casing of the blower or PAP device may be selected so thatwhen the blower is positioned against the headboard in use, the displayand on/off button are easily accessible. FIGS. 156 to 158 illustrateouter casings 5029, 5129, 5229 for a PAP device according to alternativeexamples of the present technology. FIG. 156 illustrates a PAP devicehaving a generally rectangular shaped outer casing 5029 having curvedsurfaces and rounded edges. FIG. 157 illustrates a PAP device having agenerally square outer casing 5129 having curved surfaces and roundededges. FIG. 158 illustrates a PAP device having a generally taperedouter casing such that a first end is wider than the opposite secondend, the second end including the connection to the air delivery tubing.Such a tapered outer casing may assist in inserting the PAP devicewithin a cover.

7.14 Air Delivery Tubing Length and Diameter

In an example, as shown in FIGS. 50-53, the air delivery tubing 640 thatinterconnects the patient interface 630 and the PAP device 620 (PAPdevice and tubing enclosed by cover portions 650(1), 650(2) in FIGS.50-52) includes a length of about 30-80 cm, e.g., 70 cm. In an example,a length of 70 cm may be preferred as it allows free movement whilesitting bedside and lying down in any position. Lengths longer than 70cm may create more opportunities for tangling and may be cumbersome,while lengths shorter than 60 cm may be restrictive while sitting on thebedside putting the PAP system on. Also, lengths shorter than 60 cm mayfeel tethered when sitting up. Thus, the PAP system is structured toavoid a “ball and chain” effect.

In an example, the air delivery tube may include two portions, eachhaving different diameters. For example, the portion of the tube nearthe patient's face may have an external diameter of about 12 mm and theportion of the tube away from the patient's face may have an externaldiameter of about 19 mm or 22 mm, for example.

As schematically shown in FIG. 164, a tube coupler 1945 may be providedbetween the two tube portions to transition the larger diameter tubeportion 1942 (e.g., 19 mm tube) to the smaller diameter tube portion1944 (e.g., 12 mm tube). For example, as shown in FIGS. 165-170, thetube coupler 1945 includes an end portion 1945(1) adapted to engage thelarger diameter tube portion 1942 and an end portion 1945(2) adapted toengage the smaller diameter tube portion 1944. As illustrated, the endportion 1945(1) includes a smooth exterior surface 1946-1 adapted toengage the smooth interior surface of the larger diameter tube portion1942 and a smooth, tapered interior surface 1946-2 adapted to transitionairflow from the larger diameter tube portion 1942 to the smallerdiameter tube portion 1944. The end portion 1945(2) includes a grooved,interior surface 1947 adapted to engage the ribbed, exterior surface ofthe smaller diameter tube portion 1944. In an example, as shown in FIG.169, the transition angle α may be about 10-30°, e.g., 15°. FIG. 171shows the tube coupler 1945 and tube portions 1942, 1944 with the largerdiameter tube portion 1942 attached to a PAP device 1920.

In an alternative example, the air delivery tube may be in the form of aone piece structure which tapers along its length or includes anintegral tapered section, i.e., single tube without a separate tubecoupler to transition tubing.

7.15 Nasal Interface and Pivot Point

The wrap-type PAP system (e.g., see FIGS. 13-18) may include a wrap-typepatient interface (e.g., nasal interface or nozzle/nasal prongarrangement), which exposes the patient's mouth and may work well forback, side, and stomach sleepers. Also, the wrap-type PAP system avoidsa blower on the patient's forehead. The wrap-type PAP system provides anunobtrusive arrangement, e.g., humanizing arrangement like a scarf.

As shown in FIGS. 58 and 59, the nozzle/nasal prong arrangement 730includes a one-piece structure including a base portion 735 defining anasal breathing cavity and a pair of nozzles 731 provided to the baseportion. Extended connectors 737 (e.g., headgear connectors) areprovided to sides of the base portion. A vent 732 is provided in thebase portion, preferably to a center of the base portion, i.e., centeris preferred as side-venting may be restricted in certain sleepingpositions. In an alternative arrangement, the nozzles may be formedseparately from the base portion and attached thereto, e.g., FIG. 60shows exemplary base portion 835 with extended connectors 837,

Each lateral side of the base portion includes an inlet or inlet opening732 structured to communicate with the air delivery tubing 740, e.g.,via an angled elbow joint 745 as best shown in FIGS. 54 to 57. As shownin FIGS. 54 and 55, the elbow joint 745 may be coupled to either side ofthe base portion, which allows selective positioning of the air deliverytubing 740, e.g., depending on sleeping position. The elbow joint 745may be coupled to the base portion by a swivel ring to permit rotationor swiveling of the elbow joint with respect to the base portion asshown in FIG. 56. Also, a swivel 746 may be provided to the opposite endof the elbow joint 745 and adapted to be connected to the air deliverytubing 740 as shown in FIG. 57.

In an example, structure may be provided to bias the air delivery tubingupward (i.e., toward the top of the pillow) and allow for better tubemanagement in various sleeping positions.

In an example, structure may be provided to allow the angle ofpresentation of the patient interface to be adjusted, e.g., providepivot or allow rotation of the patient interface,

7.16 Reversibility

As noted above, the PAP system may be reversible, i.e., air deliverytubing may extend from either side of the patient interface.Reversibility addresses the usability case of sitting in bed, beforelying down. Same-side orientation keeps the tube in the right positionas the patient adjusts for sleep. If the system is not reversible, itmay feel more tethered or constrained.

Reversibility also allows the system to be separated from the bedpartner. Because the system is a personal device, the air deliverytubing should be positioned on the opposite side of the face from thebed partner.

FIGS. 61, 62, and 63 show an exemplary reversible PAP system. In thisexample, the PAP system includes a patient interface 930 (e.g.,nozzle/nasal prong arrangement) supported within a cover 950(1)including side strap portions 951 to support the system on the patient'shead. The patient interface 930 includes a pair of inlet openings 932that align with respective openings provided in the cover 950(1). An airdelivery tube 940 is supported within a cover 950(2) and structured tointerconnect the patient interface and the flow generator. The airdelivery tube 940 includes an end portion 940(1) adapted to engage oneof the inlet openings 932, e.g., flexible connection, snap-in connectionvia a sleeve provided to the patient interface. A plug or button 947engages the other of the inlet openings. In addition, the plug or buttonextends through an opening in the cover 950(2) to secure the end of thecover in position. FIGS. 62 and 63 show a primary position of the airdelivery tubing and reversed position of the air delivery tubing.

FIGS. 64 to 71 illustrate a PAP system according to another example ofthe present technology. In this example, the PAP system includes a PAPdevice 1020, an air delivery tube 1040, a patient interface 1030 (e.g.,nozzle/nasal prong arrangement), and headgear 1070 to support thepatient interface in a desired position on the patient's face.

The patient interface includes a pair of inlet openings 1032, one ofwhich engages the air delivery tube 1040 (e.g., via a seal ring betweenthe inlet opening and air delivery tube) and the other of which engagesa plug 1047. The headgear 1070 includes a generally circular rear strap1071 adapted to engage or cup the patient's occiput and a front strap1072 that extends from the rear strap to support the patient interface.Side strap portions 1072(1) of the front strap may adjustably andreleasably engage respective sides of the rear strap 1071, e.g., via ahook and loop fastening arrangement. However, the front strap and rearstrap may be integrally formed as a one piece structure.

The front strap 1072 includes openings 1073(1) to receive respectivenozzles 1031 of the patient interface 1030 therethrough, and connectiontabs 1075 to interlock with respective openings provided to extendedconnectors 1037 of the patient interface. Each side strap portion1072(1) may include rigidizer or stiffening element 1076 to add rigidityto the side strap portions for stably supporting the patient interfacein position.

A cover 1050 substantially encloses one or more portions of the PAPdevice 1020 and the air delivery tubing 1040. In an example, the powercord 1029 (e.g., see FIG. 67) for the PAP device 1020 may be in the formof a generally flat strap, e.g., versus a typical round cord.

In an example, a humidifier may be incorporated into the system toprovide humidification.

In an example, the rigidizer or stiffening element may be structured toprovide rigidity in some planes yet allow flexibility or adjustment inother planes. For example, the rigidizer may include a line of weakness,hinge, scoring, and/or joint (e.g., Thermoplastic Elastomer (TPE) joint)to allow flexibility or adjustment.

7.17 Connection and Alignment

In an example, the headgear supporting the patient interface may includeconnection and alignment tabs to connect and properly align the patientinterface.

For example, as shown in FIG. 72, each rigidizer 1076 provided to theside strap portion 1072(1) of the headgear may include a connection tabor element 1075. The connection tab may, be integrally molded into therigidizer, e.g., formed via heat swage. In use, as shown in FIG. 73, theconnection tabs interlock within respective openings 1037(1) provided tothe extended connectors 1037 of the patient interface 1030 (e.g.,including nasal cushion or nasal interface). In an example, the patientinterface may have common characteristics with the mask described in PCTApplication No. PCT/AU2010/000684, filed Jun. 2, 2010, which isincorporated herein by reference in its entirety. Alternatively, asshown in FIG. 73, the tabs 1075 may be in the form of rivets structuredto extend through or be riveted to the side strap portions 1072(1). Inan example, each tab may be riveted in from one side of the fabric strapportion and the other side of the fabric strap portion may hide therivet.

In an example, the straps of the headgear include a foam/fabric laminatewith possible thermoplastic polyurethane (TPU) bonding. Edges of thestraps may be sono-bonded for cleanliness. Sewing may be used, e.g.,where material creates a complex connection.

In another example, as shown in FIGS. 74 and 75, a snap-on post 1175 maybe provided to the rigidizer 1076 of the side strap portion 1072(1), anda ring 1137(1) may be provided to respective extended connectors 1037 ofthe patient interface to engage the post. The patient interface may beformed via two-part mold with the ring being a different durometer ofsilicone than the remainder of the patient interface.

The front strap may also include one or more alignment nubs orprotrusions to align the patient interface and maintain its position.For example, FIG. 76 shows a single central alignment nub 1077 providedto the front strap 1072 and adapted to align the patient interface 1030(e.g., including nasal cushion or nasal interface). In FIG. 77, thefront strap includes a pair of alignment nubs 1077 adapted to engagerespective recesses 1039 provided to the patient interface 1030. In FIG.78, the alignment nubs may be in the form of magnets 1177 (e.g.,neodymium magnets adhered to fabric strap) structured to magneticallyinterface with metal inserts 1139 provided (e.g., co-molded) to thepatient interface.

In another example, as shown in FIGS. 79, 80, and 81, the extendedconnectors or wings 1037 of the patient interface 1030 may be tuckedinto the side strap portions 1072(1) of the headgear. As illustrated,the extended connectors 1037 are tucked under the fabric and at least aportion of the connector 1037 extends alongside the rigidizer 1076provided within the side strap portion. This arrangement minimizes theoverall impact and appearance of the connection between the patientinterface and headgear.

FIG. 172 shows another example of a rigidizer 2276 structured to extendfrom ear to ear across the front of the patient interface to providesufficient sealing force for the cushion or nozzle arrangement. In anexample, the rigidizer may be structured such that it is laterallyflexible but vertically stiff in use.

In an alternative example, as shown in FIGS. 173 and 174, the rigidizermay be provided in two parts structured to interlock with one another,i.e., first rigidizer portion 2276-1 attachable to second rigidizerportion 2276-2. In the illustrated example, the first and secondrigidizer portions 2276-1, 2276-2 are attached by a hook and snaparrangement, e.g., first rigidizer portion 2276-1 includes hook 2273adapted to engage within opening 2275 provided to second rigidizerportion 2276-2 and second rigidizer portion 2276-2 includes a protrusion2277 adapted to engage within opening 2279 provided to first rigidizerportion 2276-1, e.g., with a snap-fit. However, it should be appreciatedthat the first and second rigidizer portions 2276-1, 2276-2 may beattached to one another in other suitable manners.

The cushion 2235 includes a protrusion 2236 (e.g., including one orvents) adapted to engage within the opening 2275 and an inlet tube 2237adapted to extend through opening 2278 in the second rigidizer portion2276-2. Such arrangement locates and retains the cushion to therigidizer.

FIGS. 175 to 179 show alternative examples for attaching the cushion tothe frame or rigidizer of the patient interface. For example, FIG. 175shows a rigidizer 2376 including barbed or hook-like retaining members2376-1 adapted to locate and retain the cushion. Also, the rigidizer2376 includes a tube portion 2376-2 adapted to locate and engage theinlet of the cushion. In FIG. 176, the rigidizer 2476 includes aprotrusion 2476-1 adapted to engage within the opening 2436 provided tothe cushion 2435 and a tube portion 2476-2 adapted to engage inlet 2437of the cushion. In this example, the rigidizer provides vents and isconfigured and arranged to allow the cushion to seal on the rigidizer.In FIGS. 177 and 178, the rigidizer 2576 provides a tube portion 2576-1and an opposed opening (not visible) adapted to locate and align with atube 2535-1 and opposed opening 2535-2 provided to the cushion 2535. Inthis example, an inlet tube 2540 is provided to the tube portion 2576-1and a plug-type vent 2545 is provided to the opposed opening, which helpto locate and retain the cushion to the rigidizer. In FIG. 179, therigidizer 2676 provides a tube portion 2676-1 adapted to locate andretain a tube portion 2636 provided to the cushion 2635. In thisexample, a vent may be integrated with the tube 2640 and/or tube portion2676-1.

In another example, the cushion may be supported by a cradle which canbe rotated relative to rigidizers provided to the side strap portions ofthe headgear. This arrangement allows the cradle and hence the cushionto be rotated to allow adjustment to suit the naso-labial angle for alarge range of patients. An indexing and/or friction joint may beprovided between the cradle and the rigidizers to provide sufficientrotation torque, e.g., to provide tactile/audible feedback, to reducetube drag.

In another example, the cradle supporting the cushion may be fixed withrespect to the rigidizers, and the cushion may be rotatable relative tothe cradle to allow adjustment.

7.18 Rotating Rigid Elbow

In an example, as shown in FIGS. 82 to 84, a rotating rigid elbow 1245may be provided between the patient interface 1230 (e.g., includingnasal cushion or nasal interface) and the air delivery tube 1240. Asillustrated, each inlet opening 1232 of the patient interface includes acircular cut, e.g., at 45°, to create an ellipse. In an example, theelbow may be made from an elastomeric or flexible component to allow theair delivery tube to rotate even though connected to patient interface.Such arrangement may facilitate connection, allow flexibility tomovement, and/or provide improved sealing between the elbow and the airdelivery tube. Also, such arrangement will prevent some tube drag fromdisengaging the patient interface from the patient's face. The elbow1245 includes a first end with an angled connector 1245(1) adapted toengage the inlet opening and a second end 1245(2) adapted to engage theair delivery tube. The elbow connects and rotates at an angle withrespect to the patient interface. In an example, as shown in FIG. 85, agusset, bellows or flexible portion 1246 may be provided to the elbow,e.g., for strain relief.

Advantages of such arrangement include: minimized bend radius; flexibleorientation while sleeping, can move the air delivery tube out of theway; allow for complex shapes and transitions; optimizes aesthetic atnose area; and/or non-collapsible.

7.19 All-in-One Patient Interface and Air Delivery Tube

In an example, as shown in FIGS. 86 and 87, the air delivery tube 1340may be integrally molded in one piece (e.g., molded of silicone) withthe patient interface 1330 (e.g., including nasal cushion or nasalinterface) to provided a one-piece structure.

Advantages of such arrangement include: single part; complex geometriespossible; can use multiple durometers for different densities; caninclude gusseting/strain relief; and/or can vary cross-section of airdelivery tube.

As illustrated, the patient interface may include a nasal cradlearrangement as described in U.S. patent application Ser. No. 13/321,981,filed Nov. 22, 2011, which is incorporated herein by reference in itsentirety.

7.20 Direct Connection with Flexible Tube

In an example, as shown in FIGS. 88 and 89, the patient interface 1430(e.g., including nasal cushion or nasal interface) may have a directconnection with the flexible air delivery tube 1440. The radius of theinlet opening 1432 in the patient interface may be determined by thesize of the tube and/or the size of ribbing provided to the tube.

Advantages of such arrangement include: can use complex compositetubing; can achieve very flexible tubes; minimizes cost on the tubing;and/or can achieve tight bend radii with right construction and radiusof tube.

In an alternative example, the patient interface may have a ball andsocket type connection with the air delivery tube, e.g., the end of theair delivery tube includes a ball adapted to snap-fit into a socketprovided to the inlet opening of the patient interface so as to retainthe tube to the patient interface. Such ball and socket type connectionmay function as an exclusive connection so the interface may not be usedwith components from a conventional CPAP device as described below.

7.21 Exclusive Connection

In an example, the PAP system may be structured such that it won't allowthe use of other masks, blowers, and/or tubing, e.g., CPAP masks, CPAPblower, CPAP tubing. Thus, the patient cannot replace the patientinterface with a CPAP mask and/or replace the blower with a CPAP blower,for example. Conversely, the subject PAP system may be structured suchthat its components, e.g., patient interface, cannot be used in aconventional CPAP device. For example, the subject patient interface mayinclude structure to prevent connection to a conventional CPAP airdelivery tube.

The subject PAP system is structured for different applications (e.g.,snore detection, diagnostics), different pressures (e.g., 0-8 cmH₂O,e.g., 2-6 cmH₂O), and/or different sealing requirements than aconventional CPAP device (e.g., pressure in the range of 4-30 cmH₂O,e.g., 10-12 cmH₂O), and therefore it may not be desired to allow use ofsuch system with any components from a conventional CPAP device.

7.22 Induction Power Example

In an example, the blower of the PAP system may be powered by induction.For example, as shown in FIGS. 90 to 92, a charging mat 1590 may beplaced under the bed sheet (e.g., fitted sheet to secure it in position)adjacent the top end of the bed. The charging mat 1590 may be pluggedinto an outlet. As shown in FIG. 91, the charging mat 1590 includes auser interface 1592 (e.g., having glowing lights or an illuminateddisplay) that shows user inputs and feedback though the bed sheet. Theblower (e.g., enclosed within a cover 1550) may be attached or otherwisecoupled to the charging mat 1590, e.g., magnetically attached. Power tooperate the blower may then be delivered by the charging mat through thesheets/cover to the blower.

8. Examples of PAP Device and Cover

FIGS. 93 and 94 show a PAP device 1620 and FIG. 95 shows such PAP deviceenclosed by a cover 1650 according to an example of the presenttechnology. As illustrated, the PAP device 1620 includes a central orsymmetrical outlet 1621 structured to communicate with the air deliverytube 1640. The air intake 1623 includes a continuous pattern, and mayinclude a removable filter. A large push button 1660 is provided to thetop of the PAP device and reveals a numeric or digital display below.The digital display provides clear and understandable feedback toenhance compliance. As best shown in FIG. 94, the housing (e.g.,constructed of plastic) of the PAP device provides an exterior surfacewith a smooth, continuous taper.

The cover 1650 (e.g., constructed of a fabric material or textilematerials) allows the numeric display from the button 1660 to glowtherethrough, e.g., see FIG. 95. A filter-type fabric portion 1650(1) ofthe cover 1650 covers the air intake, e.g., enhancing the feeling ofclean air. A fitted fabric may be bonded on both sides of the airdelivery tube. In an example, the fabric cover may be structured tomuffle or suppress noise. Also, the cover may be seamless, e.g., toavoid sharp or rough edges.

FIGS. 96, 97, and 98 show a PAP device 1720 and FIG. 99 shows such PAPdevice enclosed by a cover 1750 according to another example of thepresent technology. As illustrated, the PAP device 1720 includes anoffset or asymmetrical outlet 1721 structured to communicate with theair delivery tube 1740. An overmolded, relatively soft interface button1760 is provided to the top of the PAP device, e.g., soft to push. AnLED display 1761, e.g., shows status using lights and/or icons, may beprovided adjacent the button, e.g., see FIG. 97. In an alternativeexample, as shown in FIGS. 126 to 128, the display 1761 may include anumeric or digital display as described above and adapted to glowthrough the cover 1750 in use. The housing of the PAP device includesovermolded top and bottom housing parts 1727(1), 1727(2) (e.g.,constructed of plastic) and a layered, intermediate portion 1727(3)between the housing parts. The air intake 1723 is folded in or otherwiseprovided within the layers of the intermediate portion, and iscontinuous around the perimeter.

The cover 1750 (e.g., constructed of a fabric material) includes anexterior button 1751 sewn to textile, which registers with the softinterface button below. A fitted fabric may be bonded on one side of theair delivery tube. A portion of the cover, e.g., end portion 1750(1),may include a silicone material, e.g., to keep the PAP device frommoving in bed.

FIG. 100 shows a PAP device 1820 and FIGS. 101 and 102 show such PAPdevice enclosed by cover portions 1850(1) and 1850(2) according toanother example of the present technology. As illustrated, the PAPdevice 1820 includes a central or symmetrical outlet 1821 structured tocommunicate with the air delivery tube 1840. A raised interface button1860 is provided to the top of the PAP device and a numeric display maybe provided below the button. The housing 1827 of the PAP deviceincludes a continuous hole pattern which covers the blower, e.g., blindholes. The air intake 1823 is exposed near the outlet 1821 (i.e., someof the holes in the hole pattern of the housing are open while all otherholes in the hole pattern are blind or closed).

A cover portion 1850(1) is in the form of a translucent silicone sleevewhich fits over the lower portion of the PAP device. The silicone sleeveprovides grip, e.g., to keep the PAP device from moving in bed, and alsoreveals the hole pattern of the housing. The numeric display glowsthrough the hole pattern and the silicone sleeve, e.g., see FIG. 102.The cover portion 1850(2) includes a fabric cover 1850(2)-1 that coversthe upper portion of the PAP device and a silicone band 1850(2)-2 thatstretches over the button 1860 and housing to secure the cover inposition. The fabric cover of the cover portion 1850(2) may be bonded onboth sides of the air delivery tube.

FIGS. 106 to 125 show a PAP system according to another example of thepresent technology. As illustrated, the PAP system includes a PAP device2120, a patient interface 2130 (e.g., including nasal cushion or nasalinterface (see FIG. 117)), and air delivery tubing that interconnectsthe patient interface and the PAP device. A cover 2150 substantiallyencloses the PAP device and the air delivery tubing. Also, headgear 2170supports the patient interface in position. In an example, at least aportion of the exterior surface of the tubing (and/or the interior ofthe pouch portion) may be relatively slippery (e.g., lower frictionsurface) to facilitate assembly of the tubing through the opening 4351of the pouch portion 4350-1 and into the tube portion 4350-2 of thecover 4350 (e.g., FIG. 148-1). In another example, a zipper 4451 orother releasable attachment mechanism may be provided along a length ofthe cover 4450 (e.g., along a side of the pouch portion 4450-1 and tubeportion 4450-2 of the cover) to allow easy access to connect andassemble the tube within the cover (e.g., FIG. 148-2). In anotherexample, the cover 4550 may include one or more splits 4551 along itslength to facilitate assembly of the tubing into the cover, e.g., split4551 along end of pouch portion 4550-1 and split 4551 along end of tubeportion 4550-2 (e.g., FIG. 148-3).

As best shown in FIGS. 108 and 112, the pouch portion 2150-1 of thecover enclosing the PAP device includes a zipper or other suitableclosure device to allow easy access to the PAP device. Also, at leastone side of the pouch portion may include a non-slip pattern 2151 (e.g.,see FIGS. 108, 111, 112, 124, 125) to help maintain the pouch portion inposition on a surface (e.g., bed sheets) in use. Also, an elastic bandor strip 2152 (e.g., cobalt nylon lycra strip) may be provided along thepouch portion, e.g., to help locate and secure the PAP device within thepouch portion (e.g., see FIGS. 113, 124, 125). The headgear 2170includes a generally circular rear strap 2171 (e.g., see FIGS. 115, 116,121 and 122) that provides a “halo” type arrangement adapted to engagethe patient's head, i.e., capture the crown of the patient's head inuse. A front strap 2175 extends from the rear strap to support thepatient interface. The rear strap includes slots 2171-1 on opposingsides thereof (e.g., see FIGS. 116, 118, 119, and 121) adapted toadjustably and releasably engage ends or side strap portions of thefront strap, e.g., via a hook and loop fastening arrangement. Thepositioning of the slots 2171-1 (e.g., along the sides of the “halo” orloop type arrangement, e.g., see FIG. 121) is selected to properlyorient and position the front strap 2175 to ensure correct functioningand tensioning vectors for sealing. The side strap portions of the frontstrap may include a rigidizer or stiffening element to add rigidity tothe side strap portions for stably supporting the patient interface inposition, e.g., similar to the circular rear strap 1071 and rigidizedside strap portions 1072(1) shown in FIG. 66.

FIGS. 117 and 120 show the patient facing and outer facing portionsrespectively of the PAP system that is adapted to engage a patient'sface. The patient interface 2130 may include a nasal cushion or nasalinterface that seals against the patient's face in use. The headgear2170 wraps across the outer surface over the patient interface 2130.

FIGS. 180 to 182 show alternative views of the cover 2150, headgear2170, and patient interface 2130 of the PAP system described above. Thecover 2150 completely encloses the entire system to provide animpression of an all-in-one or complete system rather than separatecomponents. The cover may also reduce the medical look of the system andhide, veil or conceal the connection points between the differentcomponents of the system, such as, the patient interface, air deliverytubing and PAP device connection points. As shown, the system may havedifferent textiles, e.g., textile T1 and textile T2, on opposing sidesof the system that may assist in orienting the system. The type oftextile may be selectable by the patient.

FIGS. 183 to 189 also show alternative views of the cover 2150, headgear2170, and patient interface 2130 of the PAP system described above, andshow the PAP system in position with the patient interface and a portionof the air delivery tubing on a patient's head and the PAP deviceportion within the scarf-like cover located over the patient's shoulderwhen the patient is in the upright position (FIGS. 183-184) and besidethe patient (FIG. 186) when the patient is in the supine position. Aback headgear strap supports the patient interface 2130 and a portion ofthe air delivery tubing within the cover 2150 on the face as seen inFIG. 185. FIG. 187 illustrates the patient holding the PAP deviceportion of the PAP system within the cover 2150. The advantage of thewrap or scarf-like arrangement means that the system is more portable,small, and lighter to allow the patient to freely move around even whenconnected to the system. FIGS. 188 and 189 illustrate the patientinterface arrangement and the connection to the cover 2150.

FIGS. 190 and 191 show an example of a front strap for headgearaccording to an example of the present technology. As illustrated, thefront strap 2275 includes side strap portions 2275-1 adapted to engagerespective slots on opposing sides of the “halo” type rear strapdescribed above, e.g., via hook and loop fastening arrangement. The sidestrap portions may be compressed (e.g., 2 mm thickness) to facilitateinsertion through the slots. The central portion 2275-2 of the frontstrap is structured to support the patient interface (e.g., nozzlearrangement, nasal cushion) and includes an opening 2276 that allows airdelivery tubing to communicate with the patient interface. Sides of thecentral portion may include a tag 2277-1 and/or tube member 2277-2wrapped around the strap (e.g., constructed of cobalt nylon lycra andattached by ultrasonic welding), e.g., for identifying informationand/or for retaining portions of the cover in use.

In an alternative example, the cover may be structured to only cover aportion of the PAP device while leaving the remaining portion of the PAPdevice exposed. For example, FIGS. 159 to 162 illustrate examples ofcovers 5350 including a strap portion 5355 adapted to wrap around thePAP device 5320 and FIG. 163 illustrates an example of a cover 5450including a pouch 5455 adapted to receive and enclose a side of the PAPdevice 5420.

8.1 Occlusion Prevention

As shown in FIGS. 96, 98, 100, and 101, at least a portion of the airintake to the PAP device is provided adjacent to the outlet or outlettube. If the PAP device is used without a cover, the outlet tubeprotrudes sufficiently past the air intake to engage bed sheets or otherobstructions and create a small gap or gaps surrounding the air intake,e.g., gap or gaps G shown in FIGS. 96 and 100. Such gaps preventocclusion of the air intake in use, e.g., if the PAP device is coveredby bed sheets.

If the PAP device is used with a cover as shown in FIGS. 99 and 102 forexample, the cover is bonded to the air delivery tube or otherwiseformed to create a gap or gaps within the cover adjacent to the airintake, e.g., gap or gaps G in cover shown in FIGS. 99 and 102, toprevent occlusion. The gaps may also help to muffle or suppress noise.In addition, the fabric material of the cover may help to muffle orsuppress noise. It should be appreciated that the cover is constructedof fabric or other suitable materials (e.g., weave, layers, etc.) thatallow air therethrough to the air intake.

9. Exemplary PAP Device

In an example, the PAP device includes a housing that encloses a blowerfor generating a supply of pressurized air and other internalcomponents. For example, along with the blower, the housing encloses orotherwise supports a suspension device, driver circuitry, a userinterface, a power supply (e.g., battery or direct), a filter, adampening device (e.g., foam), and/or a bladder.

As schematically shown in FIG. 103, the blower 2025 within housing 2065may be communicated with a bladder 2080 structured to expand andcontract in response to patient expiration and inspiration. For example,the bladder 2080 may expand (e.g., as shown in dashed lines) duringpatient expiration (e.g., due to back flow) and subsequently contractduring patient inspiration (e.g., contraction of bladder may providebolus of air to patient).

Such bladder arrangement may allow the use of a constant speed blower,as the bladder helps deal with expiratory positive airway pressure(EPAP), inspiratory positive airway pressure (IPAP), pressure swings,etc.

As schematically shown in FIG. 104, the blower 2025 may be supportedwithin the housing 2065 by a suspension device 2082, e.g., constructedof silicone, to keep the blower out of contact with the housing andallow movement of the blower with respect to the housing in use. In anexample, the suspension device 2082 may be integrated with the bladder2080. As illustrated, the suspension device 2082 includes generallyS-shaped support members 2082(1) structured to absorb shock applied tosides of the housing as well as top and bottom walls of the housing,e.g., absorb shock applied both axially and radially.

In an example, the suspension device includes an overall exterior shapethat substantially matches the shape of the housing interior. However,the suspension device may include other suitable shapes that may notcorrespond to the housing shape, e.g., suspension device includes ageneral cylindrical shape while housing includes a general rectangularshape. Also, the suspension device may include one or more side wallswith windows or openings to reduce material and help avoid resonantfrequency and its associated vibrations.

FIG. 105 schematically shows a printed circuit board (PCB) 2090including driver circuitry 2092 for controlling the blower and a userinterface, e.g., display 2094, user inputs, etc. In an example, the PCBmay include one or more monitors to monitor the patient, e.g.,temperature sensor 2094(1), microphone 2094(2), etc. The microphone ispreferably but not necessarily provided in the air flow path.

10. Evaluation Result

In an example, a microphone may monitor the patient's breathing andnoises imparted while the patient sleeps, e.g., snoring, and providesuch information to a controller which determines a result or evaluation(e.g., snore evaluation result, quiet evaluation result, snore index,AHI, etc.) based on such information, i.e., diagnosis of problems. Forexample, the controller may analyze the amplitude and duration of thepatient's snoring (e.g., detect snores in frequency band between 0-250Hz, e.g., 30-150 Hz, or 50-150 Hz) and generate a result based on suchanalysis, such result being provided to the patient so the patient candetermine whether the current PAP system is appropriate for the patientor whether to adjust treatment, e.g., raise or lower pressure, and/orconsult a physician or dentist for different treatment, e.g., differentPAP system, CPAP system providing more pressure, mandibular advancementdevice, etc.

In an example, the result may be a quiet evaluation result equal to theratio of noise-free duration over the duration of use. That is, thequiet evaluation result provides a percentage of the night that the userwas quiet, i.e., a percentage of no snoring. As shown in FIG. 201, theduration of use is the total usage time of the system and may bemeasured from the time the system is powered on to when the system ispowered off. Leading and trailing minutes of the usage time (e.g., firstfive minutes and last five minutes) may be discarded to remove soundthat may not be snoring. As shown in FIG. 202, the noise-free durationor total quiet time is the total time that the sound level is below acertain predetermined sound threshold within the duration of use. Pausesbetween consecutive snores should not be counted as “quiet time.”

In an example, the quiet evaluation result may require a specifiedduration of usage (e.g., 1 hour, 2 hours, or more), e.g., to avoidshowing results that could be inaccurate due to lack of time/sound data.Also, in an example, the quiet evaluation result may reset after aspecified duration of non-use (e.g., resets after 3, 4, 5, or more hoursof non-use). For example, if the user does not use the system for 3hours, a new quiet evaluation result is computed the next time thesystem is turned on to ensure that the user is provided with a newresult for each nap/sleep. If the user turns off the system and thenturns it back on within 3 hours, the new session is aggregated with theprevious one to allow the result to reflect an entire night's usage,even when the user turns the system on/off continuously during the night(e.g., bathroom break, etc.).

This information may be useful in determining whether the current PAPsystem is appropriate for the patient or whether to adjust treatment,e.g., raise or lower pressure, and/or consult a physician or dentist fordifferent treatment, e.g., different PAP system, CPAP system providingmore pressure, mandibular advancement device, etc.

The display of the PAP system may provide feedback to the patient toenhance user engagement, e.g., result or analysis may provide positivefeedback to the patient that current treatment is effective, displaysimply acknowledges successful night of treatment, display acknowledgesa percentage of time that room was quiet (i.e., percentage of nosnoring), etc., to help encourage the patient to make use of the deviceand to better acclimate the patient in the event morecomprehensive/upgraded therapy is required.

As noted above, the microphone may be provided to the PCB within thehousing. Alternatively, the microphone may be mounted on another part ofthe blower or on the patient interface, e.g., in the air path. Anotheralternative is to provide the microphone as a separate stand-alonedevice that may be positioned adjacent the patient and/or incommunication with the blower, patient interface.

11. Display

In an example, the display or user interface of the PAP system may berelative simple, e.g., on/off button, series of different colored lights(e.g., LEDs). For example, the display may simply include one or morelights to provide patient feedback. For example, FIGS. 142-1 and 142-2show a non-numeric display 3460 including a bar graph to indicateresults. FIG. 143 shows a non-numeric display 3560 including a circularchart with segments to indicate results, e.g., greater proportion ornumber of segments may suggest that user should adjust degree ofpressurized air or simply suggest seeing a doctor. In one example, thedisplay may include a single light that changes color/intensity (e.g.,red, green, yellow) based on pressure, breathing pattern, etc. Forexample, FIGS. 141-1 to 141-3 show a non-numeric display 3360 configuredto change color/intensity (e.g., red, green, yellow). In an example,color/intensity may be used to indicate sleep quality, e.g., green(good), yellow (ok, but could be better), red (not good—see doctor). Inanother example, the display may include a light that changes colorbased on whether power is on or off. In another example, the display mayinclude a light indicating an operating mode and/or an error. It shouldbe appreciated that the button or display may be provided at anysuitable location, e.g., depending on desired aesthetic, electricalcomponents, etc. In an example, the LED display may include anin-mold-decoration (IMD) housing which creates a pathway for the lightfor keeping lines crisp against the fabric cover in use. For example,FIG. 144 shows a display 3660 including a black resin layer 3660-1, aclear resin layer 3660-2, and an IMD layer 3660-3 structured to providea pathway for LEDs 3665 to shine therethrough. In an example, the sizeof the button may be increased to increase the available space for adisplay and hence increase the numerical height of the numerical displayin use, e.g., display diameter may be in the range of about 20-40 mm(e.g., display diameter DD1 about 27 mm in FIG. 139 and display diameterDD2 about 37 mm in FIG. 140) with a numerical height in the range ofabout 5-15 mm (e.g., numerical height NH1 about 7 mm in FIG. 139 andnumerical height NH2 about 14 mm in FIG. 140).

In an example, the display or user interface is structured to assureproper usage of the system (e.g., alerting user when a failure occurs(e.g., improper seal, blocked airflow), alerting user when system isused correctly), enhance trust (e.g., accessible and understandable userinterface will provide user with confidence in using the system), and/orprovide proper feedback (providing user with feedback that system ishelping will ensure continued usage).

The user interface may include alternative configurations to indicatestatus of the system. For example, FIGS. 129 and 130 illustrate anexample of a user interface, i.e., an on/off button, including abi-color (e.g., red, blue) LED 3060 to indicate status of the device.The fabric cover or wrap 3050 of the system which encloses the PAPdevice and the on/off button includes stitching 3051 to indicate wherethe button is located. The cover may also include a recessed portionadapted to align with the button to help locate the button's position.In use, the user may locate the button by feeling for the recessedportion and/or by locating it visually from the stitching. The buttonmay be depressed to turn the system on/off. In an example, one color ofthe LED 3060 (e.g., a blue light) may indicate that the device isworking correctly, and another color of the LED 3060 (e.g., a red light)may provide a warning that something is wrong with the device or thatthe device is not being used properly, e.g., blower overheated (e.g.,blocked airflow) or had to shut down for any other reason (such asimproper nose seal).

In another example, as shown in FIGS. 131-134, the user interface, i.e.,an on/off button, includes a tri-color (e.g., red, blue, and yellow)light ring 3160 to guide the user and indicate status of the device. Asnoted above, the fabric cover 3150 may include stitching 3151, and/or arecessed portion to indicate where the button is located.

In use, as shown in FIG. 132, the light ring 3160 glows in a full circlewhen the device is turned on to indicate that the device is starting up.As the user breaths through the nose piece, the brightness of the lightring changes, e.g., light ring includes pulse-width modulation orsimilar to vary light intensity. For example, when the user exhales, thering 3160 becomes brighter (e.g., see FIG. 133) and when the userinhales, it dims (e.g., see FIG. 134). The system shows awareness bypulsing the light ring in the same rhythm as the user's breathing, whichincrease the user's trust in the device.

In an example first time use, the user may put on the patient interfaceand feel unsure of what to do., e.g., the user feels air coming throughthe patient interface but is intimidated by the sensation. The systemmay detect that airflow is not being sent properly and the light ringturns to yellow, e.g., user isn't breathing or nozzle arrangement isoff/blocked. The user sees this and knows that they are doing somethingwrong. As the user starts breathing, the light turns to blue and pulseswith their breathing, indicating to the user that they are using thedevice correctly. The user proceeds to go to sleep. In the middle of thenight, a pillow covers the blower which prevents it from drawing enoughair. The light ring turns to red, indicating that airflow was blocked.The user wakes up in the morning and notices that system is off. Theuser checks the device and sees the red light, thereby indicating thatthe airflow was blocked, blower overheated, or system shut down so thecan adjust its placement the next night. Such light ring arrangementguides the user and assures proper usage by indicating correct usage anderrors with the light ring.

In another example, as shown in FIGS. 135-138, the user interface, i.e.,an on/off button, includes a numeric display 3260 configured to displaya result that tells the user the percentage of the night that was quiet,i.e., percentage of no snoring. As noted above, the fabric cover 3250may include stitching 3251 and/or a recessed portion to indicate wherethe button is located. In an example, the user may depress and hold thebutton to turn the system on/off. In an example, the user maydouble-click the button to show the previous result, whether the systemis on/off.

In an example use, the user turns on the system, puts on the patientinterface, and proceeds to go to sleep. As shown FIG. 136, the display3260 shows a little animation, e.g., animation of a completing circle,indicating that the device is starting up. When the user wakes up, theuser wonders if they snored or not. The user can check the evaluationresult which tells the user a noise-free percentage, e.g., user wasquiet (snore-free) 85% of the night as shown in FIG. 135. Another usemay indicate consistently low results, and the user's partner maycomplain about snoring. This tells the user that they may have apossible medical issue and the user decides to consult a doctor. Asshown in FIG. 137, a warning, e.g., check fan display 3260-1, may bedisplayed when the system is not properly operating, e.g., blower cannotdraw air properly (e.g., intake covered and the blower overheats). Asshown in FIG. 138, another warning, e.g., adjust seal display 3260-2,may be displayed when the user needs to adjust the patient interface(e.g., nozzle arrangement), e.g., improper seal detected. As shown inFIGS. 137 and 138, the display may include backlit icons for warning.The system may include a microphone for noise detection, a timer forquiet time and usage, and sensor for measuring RPM of the blower todetect irregular airflow.

12. Alternative Inlet/Filter Arrangements

The portion of the cover along the intake opening or air inlet of thePAP device may include alternative arrangements. For example, FIGS.145-1 to 145-3 shows a cover 3750 including an elongated fabric filter3755 arranged to extend along at least the air inlet of the PAP device3720. The fabric filter provides part of the exterior cover so it iseasily accessible and easily visible to determine cleaning/replacement.In an example, the fabric filter may be removably attached to theremainder of the cover, e.g., by a hook and loop arrangement. However,the fabric filter may be attached in other suitable manners, e.g.,adhesive. In an example, the filter may be arranged to maintain theremainder of the cover in position on the PAP device, e.g., filterstructured to engage and enclose open end of cover.

FIGS. 146-1 to 146-2 show a cover 3850 including open hole 3855 adjacentthe air inlet of the PAP device 3820. Such arrangement does not restrictthe air inlet and removes the likelihood of any problems with air pathbiocompatibility.

FIGS. 147-1 to 147-3 show a cover 3950 with an open bottom 3955 adaptedto expose a filter arrangement 3925 provided to the PAP device 3920. Asillustrated, the filter arrangement 3925 includes a filter 3925-1 and adoor structure 3925-2 to retain the filter to the PAP device. The bottomof the cover adjacent the open bottom includes an elastic band 3956 thatallows the cover to be pulled back from the filter arrangement for easyaccess and cleaning/replacement. The open bottom allows the filterarrangement to easily accessible and easily visible to determinecleaning/replacement. Also, the open bottom provides an unrestricted airpath so biocompatibility and restricted inlet are low risk. FIGS. 152-1to 152-3 show another example a cover 4050 with an elastic band 4056adjacent the open bottom to facilitate access of the filter arrangement4025. In this example, the filter arrangement 4025 includes a one-pieceremovable filter with a pull-tab 4025-1 to facilitate removal.

FIGS. 153-1 to 153-3 show a cover 4150 with a removable pillow slip 4155adapted to expose a filter arrangement 4125 provided to the PAP device4120. As illustrated, the filter arrangement includes a one-pieceremovable filter with a pull-tab 4125-1 to facilitate removal.

FIGS. 155-1 to 155-3 show a cover 4250 with a single zipper 4255 alongthe pouch portion thereof to access the PAP device 4220 and its filterarrangement 4225. As illustrated, the filter arrangement 4225 includes aone-piece removable filter with a pull-tab 4225-1 to facilitate removal.

13. Exemplary Cover Manufacturing Techniques

In an example, as shown in FIG. 149, the cover 4650 may include a singlepiece of textile material that is folded over and attached along itslength by a single seam to form the pouch portion 4650-1 and tubeportion 4650-2 of the cover. In an example, the pouch portion and tubeportion may be provided as separate pieces of textile material thatattached to one another, e.g., overlapped and attached by seam tape orattached by stitching.

A zipper 4651 (e.g., single direction zip) is provided along an end ofthe pouch portion (e.g., bound with heat melt TPU film) to releasablyclose the end. However, the end of the pouch portion may beopened/closed in other suitable manners, e.g., elastic band 3956 (e.g.,FIGS. 147-1 to 147-3), pillow slip 4751 provided to end of cover (e.g.,FIG. 150), or drawstring 4851 provided to end of cover (e.g., FIG. 151).

In other examples, the cover may be manufactured using a single piece oftextile material that is folded over and attached along its length by,e.g., seam tape (e.g., which may include texturized portions, pipingdetail, etc.), an ultrasonic roller (e.g., which provides a seamlessedge for reduced bulk), or circular knit.

In an example, the cover may constructed of a textile material that isdisposable, bio-compatible for skin and airway, changes color over time(e.g., over the course of 1-3 months), changes color based on airexposure and/or not UV activated. FIGS. 154-1 to 154-3 show anotherexample of a cover 4950 with a removable pillow slip 4951 adapted toexpose a filter arrangement 4925 provided to the PAP device 4920.

While the technology has been described in connection with severalexamples, it is to be understood that the technology is not to belimited to the disclosed examples, but on the contrary, is intended tocover various modifications and equivalent arrangements included withinthe spirit and scope of the technology. Also, the various examplesdescribed above may be implemented in conjunction with other examples,e.g., one or more aspects of one example may be combined with aspects ofanother example to realize yet other examples. Further, each independentfeature or component of any given assembly may constitute an additionalexample. In addition, while the technology has particular application topatients who suffer from OSA, it is to be appreciated that patients whosuffer from other illnesses (e.g., congestive heart failure, diabetes,morbid obesity, stroke, bariatric surgery, etc.) can derive benefit fromthe above teachings. Moreover, the above teachings have applicabilitywith patients and non-patients alike in non-medical applications.

1. A PAP system, comprising: a PAP device to generate a supply ofpressurized air; a patient interface adapted to form a seal with thepatient's face; air delivery tubing to interconnect the patientinterface and the PAP device; and a cover that substantially encloses atleast a portion of the PAP device and a portion of the air deliverytubing, wherein the cover allows the PAP device to be carried by and/orsupported on the patient's head.
 2. A PAP system according to claim 1,wherein the cover substantially encloses one or more portions of thepatient interface.
 3. A PAP system according to claim 1, wherein the PAPdevice generates a supply of pressurized air in the range of about 2-30cm H₂O.
 4. A PAP system according to claim 1, wherein the patientinterface includes a nozzle, nasal prong, pillow, cradle or cushionarrangement.
 5. A PAP system according to claim 1, wherein the airdelivery tubing includes two inlet tubes each adapted to pass along thepatient's cheek region, above or below the ears, and over the crown ofthe patient's head.
 6. A PAP system according to claim 5, wherein eachtube includes a non-cylindrical cross-sectional shape structured suchthat it may move between a first open phase and a second at leastpartially collapsed phase.
 7. A PAP system according to claim 1, whereinthe cover is constructed of a textile material.
 8. A PAP systemaccording to claim 1, further comprising headgear to support at leastthe patient interface and air delivery tubing on the patient's head. 9.A PAP system according to claim 1, wherein the patient interface, airdelivery tubing, cover, and/or headgear is constructed of materialsincluding different colors, patterns, and/or surface texture so as toblend in with the patient's skin and/or hair.
 10. A PAP system accordingto claim 1, wherein at least a portion of the cover is adapted to wraparound the patient's head.
 11. A PAP system according to claim 1,wherein the cover includes a wrap or scarf-like arrangement.
 12. A PAPsystem according to claim 1, wherein the cover includes a pouch portionto substantially enclose one or more portions of the PAP device and atube portion to substantially enclose one or more portions of the airdelivery tube.
 13. A PAP system according to claim 12, wherein the coverfurther includes a headgear strap portion that cooperates with anotherheadgear strap to wrap around the patient's head to stabilize andsupport the system on the patient's head.
 14. A PAP system according toclaim 1, wherein the cover is structured to hide, veil or conceal one ormore connection points between the PAP device, patient interface, andair delivery tubing.
 15. A PAP system according to claim 1, wherein thePAP device is adapted to be located over the patient's shoulder when thepatient is in an upright position and/or adapted to be located beside,near or adjacent the patient when the patient is in a supine position.16. A PAP system according to claim 15, wherein the PAP device isadapted to be located near the patient's chest when the patient is inthe supine position.
 17. A PAP system according to claim 1, wherein thesystem is portable and lightweight to allow the patient to freely movearound while wearing the system.
 18. A system for delivery ofpressurized air to a patient, comprising: a base unit including a blowerto generate a supply of air at positive pressure; a patient interfaceadapted to be provided to a patient's face; and a tube to deliver thesupply of pressurized air to the patient interface, the tube structuredto selectively modify its shape in order to move the patient interfaceand/or modify the amount of force exerted between the patient interfaceand the patient.
 19. A system according to claim 18, further comprisingan interface controller to adjust an angle of the patient interfacerelative to the patient's face.
 20. A system according to claim 18,wherein the patient interface is adapted to engage the patient's face.21. A system according to claim 18, wherein the patient interface isadapted to be positioned adjacent to the patient's face.
 22. A systemaccording to claim 18, wherein the system is adapted to fit itself tothe patient while the patient is unaware or asleep.
 23. A systemaccording to claim 18, wherein the system is adapted to provide aminimum required force to achieve satisfactory seal and comfort byadapting force and force angle provided by the patient interface in realtime.
 24. A system according to claim 18, wherein the tube includes aseries of active elements along its length, each of the active elementsstructured to selectively contract and/or extend to adjust a length ofthe tube.
 25. A system according to claim 18, further comprising a forcesensor to measure force and torque between the patient interface and thepatient's face.